Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors

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Brief Title

Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors

Official Title

Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors

Brief Summary

      RATIONALE: Germ cell tumors (GCT) are highly sensitive to chemotherapy such that even with
      metastatic disease at diagnosis, many patients can be cured. Patients who fall into the poor
      risk category or others who relapse can be successfully salvaged with high dose chemotherapy
      and autologous stem cell transplant (AuSCT). As in other diseases such as myeloma, sequential
      high dose chemotherapy and AuSCT may improve overall and disease free survival.

      PURPOSE: Because prior investigations in GCT suggest that a subset of high risk or relapsed
      patients may be cured with sequential cycles of high dose chemotherapy and AuSCT, we propose
      investigating how well non-cross resistant conditioning regimens work in treating patients
      with relapsed or high risk GCT.
    

Detailed Description

      OBJECTIVES:

      Primary

        -  Determine overall survival (OS) of patients with germ cell tumors treated with tandem
           autologous stem cell transplantation with non-cross-resistant conditioning regimens.

      Secondary

        -  Determine disease-free survival (DFS) of patients treated with this regimen.

        -  Determine the toxicity of tandem transplants

        -  Determine the time to engraftment of neutrophils and platelets in patients treated for
           each transplant

        -  Determine the number of patients unable to adequately mobilize sufficient peripheral
           blood stem cells (PBSC) for tandem transplantation.

        -  Identify prognostic factors of patients unlikely to mobilize sufficient PBSC for tandem
           transplantation.

        -  Compare OS and DFS of patients undergoing single vs tandem transplantation.

      OUTLINE:

        -  Peripheral blood stem cell (PBSC) mobilization with filgrastim (G-CSF): Patients receive
           G-CSF subcutaneously (SC) beginning on day 1 and continuing until stem cell collection
           is complete. Patients undergo stem cell collection beginning on day 5 of G-CSF
           administration and continuing for at least 3 collections until the collection goal is
           met.

        -  Second PBSC mobilization with chemotherapy: Patients not meeting the collection goal
           receive cyclophosphamide IV over 2 hours on day 1 and G-CSF SC beginning on day 4 and
           continuing until stem cell collection is complete. Patients meeting the collection goal
           after PBSC mobilization via G-CSF alone or in combination with chemotherapy will undergo
           tandem autologous transplantation. If collection goal is not met but the patient has
           collected > or = 2 x 10^6 CD34 cells/kg, a single autologous transplant will be
           performed.

        -  Single stem cell transplantation (SCT): Patients receive paclitaxel IV over 3 hours on
           day -7 and ifosfamide IV on days -6 to -4. Patients undergo reinfusion of stem cells on
           day 0. Patients also receive G-CSF SC or IV beginning on day 1 and continuing until
           blood counts recover.

        -  Tandem SCT: Patients receive treatment as in single SCT. Beginning 30-90 days later,
           patients receive carboplatin IV over 60 minutes and thiotepa IV over 30 minutes on days
           -6 to -4 and etoposide IV over 60 minutes on days -6 to -3. Patients undergo reinfusion
           of stem cells on day 0. Patients also receive G-CSF SC or IV beginning on day 5 and
           continuing until blood counts recover.

      After completion of study treatment, patients are followed at 6, 9, and 12 months and then
      every 6 months for up to 2 years.

      PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Overall survival (OS)

Secondary Outcome

 Disease-free survival (DFS)

Condition

Childhood Germ Cell Tumor

Intervention

carboplatin

Study Arms / Comparison Groups

 2 Transplants
Description:  Patients with Germ Cell Tumors (GCT) treated with a second tandem autologous stem cell transplant (AuSCT) with non-cross-resistant conditioning regimens.

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

23

Start Date

December 19, 2006

Completion Date

October 2021

Primary Completion Date

October 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis: Poor Prognosis Non-Seminomas Germ Cell Tumor in ≥ PR1/CR1 or Good or
             Intermediate Prognosis Seminomas and Non- Seminomas Germ Cell Tumor in ≥ PR1 or ≥ CR2
             as defined by the International Germ Cell Cancer Consensus Classification. Patients
             with increasing tumor markers only (i.e. no imaging evidence of progressive disease)
             are eligible for transplant.

          -  Age: ≥ 10 years and < 70 years of age.

          -  Performance status: Karnofsky ≥ 80% (subjects ≥ 16 years of age) Lansky ≥ 80% for
             subject 10 - 15 years of age

          -  Life expectancy: Greater than 8 weeks.

          -  Patients must have normal organ function as defined below:

               -  Hematologic:

                    -  Hemoglobin > 8 gm/dL without transfusion and off erythropoietin for 14 days
                       or Aranesp for 21 days

                    -  White blood cells (WBC) > 2.5 x 10^9/L with an absolute neutrophile count
                       (ANC) > 1.5 x 10^9/L and off G-CSF or GM-CSF for 10 days or Neulasta for 21
                       days

                    -  Platelets > 100 x 10^9/L without transfusion and/or a bone marrow
                       cellularity of ≥ 20%

               -  Renal: Creatinine ≤ 2.0 mg/dl or creatinine clearance > 50 ml/min.

               -  Hepatic: Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase < 5 x upper
                  limit of normal. No history of severe prior or ongoing chronic liver disease.

               -  Cardiac: Patients must be free of symptoms of uncontrolled cardiac disease
                  including unstable angina, decompensated congestive heart failure, or arrhythmia.
                  LVEF ≥45% by MUGA/ECHO.

               -  Pulmonary: Patients must have no significant obstructive airways disease (FEV1
                  must be ≥ 50% of predicted) and must have acceptable diffusion capacity
                  (corrected DLCO > 50% of predicted).

          -  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.

        Exclusion Criteria:

          -  Patients with serious uncontrolled infections will not be eligible.

          -  Male and female patients of reproductive potential must use an approved contraceptive
             method if appropriate (for example, intrauterine device [IUD], birth control pills, or
             barrier device) during and for the duration of study participation. The drugs used in
             this study are pregnancy category D - clear evidence of risk in pregnancy.

          -  Pregnant and breast feeding women will not be eligible.

        Voluntary written informed consent before performance of any study-related procedure not
        part of normal medical care, with the understanding that consent may be withdrawn by the
        subject at any time without prejudice to future medical care.

        Additional Eligibility prior to Transplant Two:

          -  Total Collection of ≥ 4 x 10^6 CD34 cells/kg prior to transplant one

          -  Transplant able to occur between day +30 and day +90 from transplant one

          -  Recovery of blood counts as demonstrated by:

               -  WBC > 2.5 x 10^9/L with an ANC > 1.5 x 10^9/L and off G-CSF for 3 days

               -  Platelets > 50 x 10^9/L without transfusion in the prior 7 days

               -  Renal: Creatinine ≤ 2.0 mg/dl or creatinine clearance > 50 ml/min

               -  Hepatic: Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase < 5 x upper
                  limit of normal

          -  Infection: Patients with serious uncontrolled infections at the time of planned
             transplant will be excluded

          -  Patients with progressive disease by Response Evaluation Criteria in Solid Tumors
             (RECIST) criteria by imaging techniques are not eligible to proceed to the second
             transplant. Tumor marker increase alone is not sufficient to diagnose disease
             progression.
      

Gender

All

Ages

10 Years - 69 Years

Accepts Healthy Volunteers

No

Contacts

Najla El Jurdi, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00432094

Organization ID

2006LS032

Secondary IDs

UMN-MT2005-21

Responsible Party

Sponsor

Study Sponsor

Masonic Cancer Center, University of Minnesota


Study Sponsor

Najla El Jurdi, MD, Principal Investigator, Masonic Cancer Center, University of Minnesota


Verification Date

September 2020