Auto Transplant for High Risk or Relapsed Solid or CNS Tumors

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Brief Title

Auto Transplant for High Risk or Relapsed Solid or CNS Tumors

Official Title

Alkylator-Intense Conditioning Followed by Autologous Transplantation for Patients With High Risk or Relapsed Solid or CNS Tumors

Brief Summary

      This is a standard of care treatment guideline for high risk or relapsed solid tumors or CNS
      tumors consisting of a busulfan, melphalan, thiotepa conditioning (for solid tumors) or
      carboplatin and thiotepa conditioning (for CNS tumors) followed by an autologous peripheral
      blood stem cell transplant. For solid tumors, if appropriate, disease specific radiation
      therapy at day +60. For CNS tumors, the conditioning regimen and autologous peripheral blood
      stem cell transplant will be given for 3 cycles.
    



Study Type

Interventional


Primary Outcome

Overall Survival

Secondary Outcome

 Number of Patients Who Achieved Transplant Engraftment

Condition

Ewing's Family Tumors

Intervention

Ifosfamide

Study Arms / Comparison Groups

 Arm A: Patients with High Risk or Relapsed Solid Tumor
Description:  Treatment consists of a mobilization chemotherapy (ifosfamide 1.8 g/m^2/day intravenously [IV], etoposide 100 mg/mg^2 IV, mesna 1.8 g/m^2 divided in every 6 hours dosing, and granulocyte colony stimulating factor 10 mcg/kg subcutaneously or IV until absolute neutrophils > 1,000/mm^2) for 5 days in a 30-100 day pretransplant window, busulfan (1.1 mg/kg IV every 6 hours on days -8 through -6), melphalan (50 mg/mg^2 on days -5 and -4), thiotepa conditioning (250 mg/m^2 IV over 2 hours on days -3 and -2) followed by an autologous peripheral blood stem cell transplant (infusion on Day 0) and, if appropriate, disease specific radiation therapy at day +60.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

October 20, 2011

Completion Date

March 2024

Primary Completion Date

March 2022

Eligibility Criteria

        Inclusion Criteria:

        All patients must have histological verification of malignancy at original diagnosis.

          -  Eligible Diseases

               -  Arm A: Solid Tumor

                    -  Ewing's Family Tumors (ES/PNET/DSRCT) - metastatic at time of diagnosis
                       and/or relapsed after therapy

                    -  Renal Tumors - relapsed (all histology - Wilm's tumor) or at diagnosis
                       (clear cell sarcoma and Rhabdoid tumor)

                    -  Hepatoblastoma - metastatic at time of diagnosis and/or relapsed after
                       therapy

                    -  Rhabdomyosarcoma - metastatic at time of diagnosis and/or relapsed after
                       therapy

                    -  Soft Tissue Sarcoma - chemotherapy responsive metastatic disease or
                       chemotherapy responsive relapsed disease

                    -  Primary Malignant Brain Neoplasms <18 years of age - at diagnosis and/or
                       relapse

                    -  Retinoblastoma - disseminated at diagnosis and/or relapsed

                    -  CNS Lymphoma - primary or secondary CNS lymphoma.

                    -  Other High Risk Metastatic or Relapsed Solid Tumors - to be approved by 2 or
                       more pediatric hematology/oncology and bone marrow transplant (BMT)
                       physicians

               -  Arm B: Certain CNS tumors

                    -  Medulloblastoma: Children less than 36 months (3 years) of age at time of
                       definitive surgery (for histopathologic diagnosis) who have high risk
                       Medulloblastoma, defined as any one of the following:

                         1. > 1.5 cm2 residual disease following resection for any Medulloblastoma
                            histology

                         2. lumbar CSF cytology positive for tumor cells by analysis of fluid
                            collected either before definitive surgery or at least 10 days after
                            definitive surgery

                         3. MRI evidence of (a) gross nodular seeding in the intracranial
                            subarachnoid space or ventricular system distant from primary tumor
                            site, M2; or (b) gross nodular seeding in the spinal subarachnoid space
                            +/- evidence of intracranial seeding, M3; or (c) extraneural
                            metastases, M4,

                    -  Anaplastic Histologic Variant Medulloblastoma: less than 70 years of age,
                       any metastatic stage, with total or sub-total resection.

                    -  Infant Medulloblastoma: Children less than 8 months of age at the time of
                       definitive surgery (for histopathologic diagnosis), any histology, any
                       metastatic state, with total or sub-total resection.

                    -  Supra-tentorial Primative Neuro-Ectodermal Tumor (PNET): Children less than
                       36 months (3 years) of age at time of definitive surgery (for
                       histopathologic diagnosis) with or without metastatic disease

                    -  Atypical Teratoid/Rhabdoid Tumor (AT/RT): less than 70 years of age with CNS
                       AT/RT (with or without metastatic disease).

                    -  Other High Risk CNS Tumors - to be approved by 2 or more physicians (at
                       least one oncologist and one BMT physician).

               -  Arm C: Germ Cell Tumors

                    -  Confirmation of germ cell tumor (GCT) histology (both seminoma and
                       nonseminoma). Tumor may have originated in any primary site. NOTE: In rare
                       circumstances, patients will be allowed to enroll even if a pathologic
                       diagnosis may not have been established. This would require a clinical
                       situation consistent with the diagnosis of GCT (testicular, peritoneal,
                       retroperitoneal or mediastinal mass, elevated tumor marker levels {HCG ≥
                       500; AFP ≥ 500} and typical pattern of metastases).

                         1. One or more unfavorable prognostic features for achieving a CR with
                            conventional-dose chemotherapy. Unfavorable prognostic features
                            include:

                         2. extragonadal primary site

                         3. PD following an incomplete response (IR) to first-line therapy,

                         4. PD after a conventional-dose salvage (cisplatin + ifosfamide -based)
                            regimen

               -  Arm D: Certain CNS Tumor patients who can only undergo one transplant

                    -  Medulloblastoma: Children less than 36 months (3 years) of age at time of
                       definitive surgery (for histopathologic diagnosis) who have high risk
                       Medulloblastoma, defined as any one of the following:

                         -  > 1.5 cm2 residual disease following resection for any Medulloblastoma
                            histology

                         -  lumbar CSF cytology positive for tumor cells by analysis of fluid
                            collected either before definitive surgery or at least 10 days after
                            definitive surgery

                         -  MRI evidence of (a) gross nodular seeding in the intracranial
                            subarachnoid space or ventricular system distant from primary tumor
                            site, M2; or (b) gross nodular seeding in the spinal subarachnoid space
                            +/- evidence of intracranial seeding, M3; or (c) extraneural
                            metastases, M4,

                    -  Anaplastic Histologic Variant Medulloblastoma: less than 70 years of age,
                       any metastatic stage, with total or sub-total resection.

                    -  Infant Medulloblastoma: Children less than 8 months of age at the time of
                       definitive surgery (for histopathologic diagnosis), any histology, any
                       metastatic state, with total or sub-total resection.

                    -  Supra-tentorial Primative Neuro-Ectodermal Tumor (PNET): Children less than
                       36 months (3 years) of age at time of definitive surgery (for
                       histopathologic diagnosis) with or without metastatic disease

                    -  Atypical Teratoid/Rhabdoid Tumor (AT/RT): less than 70 years of age with CNS
                       AT/RT (with or without metastatic disease).

                    -  Other High Risk CNS Tumors including choroid plexus carcinoma in children-
                       to be approved by 2 or more physicians (at least one oncologist and one BMT
                       physician).

               -  Arm E: Neuroblastoma ** Neuroblastoma (ICD-O morphology 9500/3) or
                  ganglioneuroblastoma (nodular or intermixed) verified by histology or
                  demonstration of clumps of tumor cells in bone marrow with elevated urinary
                  catecholamine metabolites.

          -  Disease Status at Enrollment

               -  Arm A, Arm B and Arm D must have fit one of the following:

                    -  no evidence of disease or

                    -  stable, non-progressive disease (defined as non-progressive abnormalities on
                       physical exam or CT and/or MRI) within 4 weeks of study entry

               -  Arm C: Evidence of progressive or recurrent GCT (measurable or non-measurable)
                  following one or more cisplatin-based chemotherapy, defined as meeting at least
                  one of the following criteria:

                    -  Tumor biopsy of new or growing or unresectable lesions demonstrating viable
                       non-teratomatous GCT. Patients with incomplete gross resection where viable
                       GCT is found are considered eligible.

                    -  Consecutive elevated serum tumor markers (HCG or AFP) that are increasing.
                       Increase of an elevated LDH alone does not constitute progressive disease.

                    -  Development of new or enlarging lesions in the setting of persistently
                       elevated HCG or AFP, even if the HCG and AFP are not continuing to increase.

               -  Arm E: Patients with the following disease stages at diagnosis are eligible, if
                  they meet the other specified criteria.

                    -  Patients with newly diagnosed neuroblastoma with INSS Stage 4 are eligible
                       with the following:

                         -  MYCN amplification (> 4-fold increase in MYCN signals as compared to
                            reference signals), regardless of age or additional biologic features
                            or

                         -  Age > 18 months (> 547 days) regardless of biologic features or

                         -  Age 12-18 months (365-547 days) with any of the following 3 unfavorable
                            biologic features (MYCN amplification, unfavorable pathology and/or DNA
                            index = 1) or any biologic feature that is
                            indeterminate/unsatisfactory/unknown.

                    -  Patients with newly diagnosed neuroblastoma with INSS Stage 3 are eligible
                       with the following:

                         -  MYCN amplification (> 4-fold increase in MYCN signals as compared to
                            reference signals), regardless of age or additional biologic features
                            or

                         -  Age > 18 months (> 547 days) with unfavorable pathology, regardless of
                            MYCN status.

                    -  Patients with newly diagnosed neuroblastoma with INSS Stage 2A/2B with MYCN
                       amplification (> 4-fold increase in MYCN signals as compared to reference
                       signals), regardless of age or additional biologic features.

                    -  Patients with newly diagnosed neuroblastoma with INSS Stage 4S with MYCN
                       amplification (> 4-fold increase in MYCN expression signals as compared to
                       reference signals), regardless of additional biologic features.

                    -  Patients ≥ 365 days initially diagnosed with neuroblastoma INSS Stage 1, 2,
                       4S who progressed to aStage 4 without interval chemotherapy.

          -  Age and Performance Status

               -  Age and Performance Status, Arm A

                    -  Age: 0 - 70 years

                    -  Performance status: Karnofsky Performance Status ≥ 50% for patients > 16
                       years of age or Lansky Play Score ≥ 50 for patients ≤ 16 years of age (Note:
                       Neurologic deficits in patients with CNS tumors must be stable for a minimum
                       of 1 week prior to study entry)

               -  Age and Performance Status, Arm B

                    -  Age: see Eligible diseases, section 3.1, for age criteria

                    -  Performance status: Karnofsky Performance Status ≥ 50% for patients > 16
                       years of age or Lansky Play Score ≥ 50 for patients ≤ 16 years of age (Note:
                       Neurologic deficits in patients with CNS tumors must be stable for a minimum
                       of 1 week prior to study entry)

               -  Age and Performance Status, Arm C

                    -  Age: 0-70 years of age

                    -  Performance status: Karnofsky Performance Status ≥ 70% for patients > 16
                       years of age or Lansky Play Score ≥ 70 for patients ≤ 16 years of age

               -  Age and Performance Status, Arm D

                    -  Age: see Eligible diseases, section 3.1, for age criteria

                    -  Performance status: Karnofsky Performance Status ≥ 50% for patients > 16
                       years of age or Lansky Play Score ≥ 50 for patients ≤ 16 years of age
                       (Neurologic deficits in patients with CNS tumors must be stable for a
                       minimum of 1 week prior to study entry)

               -  Age and Performance Status, Arm E

                    -  Age: Patients must be ≤ 30 years of age at the time of initial diagnosis.

                    -  Performance status: Karnofsky Performance Status ≥ 50% for patients > 16
                       years of age or Lansky Play Score ≥ 50 for patients ≤ 16 years of age

          -  Organ Function

               -  Organ Function, Arm A

                    -  Hematologic: hemoglobin of >9 gm/dl and platelet count > 20,000/μl. Patients
                       may receive transfusions as necessary.

                    -  Renal: GFR ≥ 50 ml/min/1.73m2 or serum creatinine ≤ 2.5 x ULN for age

                    -  Hepatic: AST or ALT ≤ 5 x ULN and bilirubin ≤ 5 x ULN

                    -  Cardiac: ejection fraction ≥ 45% or no clinical evidence of heart failure

                    -  Pulmonary: oxygen saturation > 92% at rest (on room air)

               -  Organ Function, Arm B (to begin first consolidation cycle)

                    -  Timing: patients must be fully recovered from radiation, induction
                       chemotherapy or surgery prior to receiving consolidation, with minimum
                       elapsed time of 2 weeks.

                    -  Hematologic: ANC > 750/μl, hemoglobin of >8 gm/dl (may receive PRBC
                       transfusions) and platelet count > 75,000/μl (transfusion independent).

                    -  Renal: GFR ≥ 50 ml/min/1.73m2

                    -  Hepatic: AST or ALT ≤ 2.5 x ULN and bilirubin ≤ 1.5 x ULN

                    -  Cardiac: ejection fraction ≥ 45% or no clinical evidence of heart failure

                    -  Pulmonary: oxygen saturation > 94% at rest (on room air)

                    -  Central Nervous System: patients with seizure history are allowed if on
                       anti-convulsants and well controlled; patients must not be in status
                       epilepticus, coma or require assisted ventilation

               -  Organ Function, Arm C (to begin TI chemotherapy)

                    -  Hematologic: ANC ≥ 750/mm3, platelets ≥ 75,000/mm3

                    -  Renal: GFR ≥ 50 ml/min/1.73m2 or serum creatinine ≤ 2.5 x ULN for age

                    -  Hepatic: AST or ALT ≤ 2.5 x upper limits of normal (ULN), if hepatic
                       involvement < 5 x ULN; bilirubin ≤ 2.0 x upper limits of normal (ULN)

               -  Arms A and C: Patients with a history of CNS tumor involvement are eligible if
                  they have completed treatment for CNS disease (radiotherapy or surgery or
                  chemotherapy), have recovered from or stabilization of the side effects
                  associated with the therapy and have no evidence of progressive CNS disease at
                  the time of enrollment

               -  Organ Function, Arm D

                    -  Timing: patients must be fully recovered from radiation, induction
                       chemotherapy or surgery prior to receiving consolidation, with minimum
                       elapsed time of 2 weeks.

                    -  Hematologic: ANC > 750/μl, hemoglobin of >8 gm/dl (may receive PRBC
                       transfusions) and platelet count > 75,000/μl (transfusion independent).

                    -  Renal: GFR ≥ 50 ml/min/1.73m2

                    -  Hepatic: AST or ALT ≤ 2.5 x ULN and bilirubin ≤ 1.5 x ULN

                    -  Cardiac: ejection fraction ≥ 45% or no clinical evidence of heart failure

                    -  Pulmonary: oxygen saturation > 92% at rest (on room air)

                    -  Central Nervous System: patients with seizure history are allowed if on
                       anti-convulsants and well controlled; patients must not be in status
                       epilepticus, coma or require assisted ventilation

               -  Organ Function, Arm E

                    -  No evidence of disease progression: defined as increase in tumor size of
                       >25% or new lesions.

                    -  Timing: Recovery from last induction course of chemotherapy.

                    -  Minimum frozen PBSC of 4 x 106 CD34 cells/kg as 2 aliquots; i.e. 2 x 106
                       CD34 cells/kg for each transplant are mandatory. A third aliquot of 2 x 106
                       CD34 cells/kg is strongly recommended for back-up.

                    -  Hepatic: AST < 3 x upper normal

                    -  Cardiac: Shortening fraction ≥ 27%, or ejection fraction ≥ 50%, no clinical
                       congestive heart failure.

                    -  Renal: Creatinine clearance or GFR > 60 ml/min/1.73m2 (If a creatinine
                       clearance is performed at end of induction and the result is < 100
                       ml/min/1.73m2, a GFR must be performed using a nuclear blood sampling method
                       or iothalamate clearance method. Camera method is NOT allowed as measure of
                       GFR prior to or during Consolidation therapy for patients with GFR or
                       creatinine clearance of < 100 ml/min/1.73m2.)

        Exclusion Criteria:

          -  Arm A, B, C, and D:

               -  Pregnant or breastfeeding

               -  Active, uncontrolled infection and/or human immunodeficiency virus (HIV) positive
                  constitute progressive disease.

               -  Concomitant enrollment on clinical study (such as COG study) that does not allow
                  co-enrollment on this standard of care protocol (Arm B only)

          -  Arm E: Pregnant or breastfeeding

               -  Active, uncontrolled infection and/or HIV positive

               -  Known contraindication to PBSC collection. Examples of contraindications might be
                  a weight or size less than that determined to be feasible at the collecting
                  institution, or a physical condition that would limit the ability of the child to
                  undergo apheresis catheter placement (if necessary) and/or the apheresis
                  procedure.

               -  Patients that are 12-18 months of age with INSS Stage 4 and all 3 favorable
                  biologic features (ie, non- amplified MYCN, favorable pathology, and DNA index >
                  1).
      

Gender

All

Ages

N/A - 70 Years

Accepts Healthy Volunteers

No

Contacts

Ashish Gupta, MBBS, MPH, 612-273-8482, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01505569

Organization ID

2011OC057

Secondary IDs

MT2011-09C

Responsible Party

Sponsor

Study Sponsor

Masonic Cancer Center, University of Minnesota


Study Sponsor

Ashish Gupta, MBBS, MPH, Principal Investigator, Masonic Cancer Center, University of Minnesota


Verification Date

May 2021