Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors

Learn more about:
Related Clinical Trial
A Phase II Trial Evaluating the Efficacy of Cabozantinib With Patients With Refractory GCTs Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT A Pilot Study of Thermodox and MR-HIFU for Treatment of Relapsed Solid Tumors Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors A Study of a New Way to Treat Children With a Brain Tumor Called NGGCT Aerosolized Azacytidine as Epigenetic Priming for Bintrafusp Alfa-Mediated Immune Checkpoint Blockade in Patients With Unresectable Pulmonary Metastases From Sarcomas, Germ Cell Tumors, or Epithelial Malignancies B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults Symptom Management for YA Cancer Survivors A Study of miRNA 371 in Patients With Germ Cell Tumors Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies Interleukin-15 Armored Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Pediatric Solid Tumors EGFR806-specific CAR T Cell Locoregional Immunotherapy for EGFR-positive Recurrent or Refractory Pediatric CNS Tumors HER2-specific CAR T Cell Locoregional Immunotherapy for HER2-positive Recurrent/Refractory Pediatric CNS Tumors Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors Aflac ST0901 CHOANOME – Sirolimus in Solid Tumors Study of Genistein in Pediatric Oncology Patients (UVA-Gen001) A Pilot RCT of the PRISM Intervention for AYAs With Cancer Simvastatin With Topotecan and Cyclophosphamide in Relapsed and/or Refractory Pediatric Solid and CNS Tumors Molecular-Guided Therapy for Childhood Cancer EGFR806 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas Recombinant Human Thrombopoietin in Children Receiving Ifosfamide, Carboplatin, and Etoposide Chemotherapy MR-guided High Intensity Focused Ultrasound (HIFU) on Pediatric Solid Tumors Tandem Peripheral Blood Stem Cell (PBSC) Rescue for High Risk Solid Tumors Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors Talabostat Combined With Temozolomide or Carboplatin in Treating Young Patients With Relapsed or Refractory Brain Tumors or Other Solid Tumors Auto Transplant for High Risk or Relapsed Solid or CNS Tumors Busulfan in Treating Children and Adolescents With Refractory CNS Cancer CpG 7909 in Treating Patients Who Have Undergone Autologous Stem Cell Transplant Development of Strategies to Increase Enrollment in Clinical Trials for Children With Cancer Ixabepilone in Treating Young Patients With Solid Tumors or Leukemia That Haven’t Responded to Therapy ABT-751 in Treating Young Patients With Refractory Solid Tumors Temozolomide and O6-benzylguanine in Treating Children With Solid Tumors Arsenic Trioxide in Treating Patients With Advanced Neuroblastoma or Other Childhood Solid Tumors Temozolomide Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Malignant Glioma or Recurrent CNS or Other Solid Tumors Collecting and Storing Tissue From Young Patients With Cancer Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Rare Cancer High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors Peripheral Stem Cell Transplantation Plus Chemotherapy in Treating Patients With Malignant Solid Tumors Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Everolimus in Refractory Testicular Germ Cell Cancer Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors Adolescent and Young Adult Cancer Patients: Cognitive Toxicity on Survivorship (ACTS) A Phase I Study of Lyso-thermosensitive Liposomal Doxorubicin and MR-HIFU for Pediatric Refractory Solid Tumors Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors First Line TIP in Poor Prognosis TGCTs. Sodium Thiosulfate in Preventing Hearing Loss in Young Patients Receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy Electroacupuncture in Treating Delayed Nausea and Vomiting in Patients Receiving Chemotherapy For Newly Diagnosed Childhood Sarcoma, Neuroblastoma, Nasopharyngeal Cancer, Germ Cell Tumors, or Hodgkin Lymphoma Disulfiram and Cisplatin in Refractory TGCTs. Role of Axumin PET Scan in Germ Cell Tumor Evaluating Immune Therapy, Duravalumab (MEDI4736) With Tremelimumab for Relapsed/Refractory Germ Cell Tumors Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx) Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors Study of the Hypomethylating Drug Guadecitabine (SGI-110) Plus Cisplatin in Relapsed Refractory Germ Cell Tumors Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients With Germ Cell Tumors Combination Chemotherapy Plus Amifostine in Treating Children With Malignant Germ Cell Tumors Study Evaluating the Impact of Short Message Service on Compliance With Surveillance of Patients With Germ-cell Tumors Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy Aprepitant + a 5HT3 + Dexamethasone in Patients With Germ Cell Tumors Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors Treatment Outcome and Quality of Life in Patients With Pediatric Extra-Cranial Germ Cell Tumors Previously Treated on Clinical Trial CCLG-GC-1979-01 or CCLG-GC-1989-01 Brentuximab Vedotin in Relapsed/Refractory Germ Cell Tumors Durvalumab Alone or With Tremelimumab in Refractory Germ Cell Tumors Etoposide, Carboplatin, and Bleomycin in Treating Young Patients Undergoing Surgery For Malignant Germ Cell Tumors Studying Biomarkers in Samples From Younger Patients With Malignant Germ Cell Tumor Progression Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Germ Cell Tumors Observation and/or Combination Chemotherapy After Surgery or Biopsy in Treating Young Patients With Extracranial Germ Cell Tumors Conventional Dose Versus High Dose Sequential Chemotherapy for Poor Prognosis Germ Cell Tumors Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors Combination Chemotherapy in Treating Children With Newly Diagnosed Malignant Germ Cell Tumors Accelerated v’s Standard BEP Chemotherapy for Patients With Intermediate and Poor-risk Metastatic Germ Cell Tumours Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors Salvage Chemotherapy for Poor Prognosis Germ Cell Tumors Autologous Peripheral Blood Stem Cell Transplant for Germ Cell Tumors Dose Intensification Study in Refractory Germ Cell Tumors With Relapse and Bad Prognosis A Novel Single Arm Phase II Study for Relapsed Germ Cell Tumours With Poor Prognosis Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors Paclitaxel, Ifosfamide and Cisplatin (TIP) Versus Bleomycin, Etoposide and Cisplatin (BEP) for Patients With Previously Untreated Intermediate- and Poor-risk Germ Cell Tumors Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors Nivolumab in Platinum Recurrent or Refractory Metastatic Germ Cell Tumors Proton Beam Radiation Therapy for Central Nervous System (CNS) Germ Cell Tumors Germ Cell Tumor and Testicular Tumor DNA Registry A Phase II Study of Sirolimus and Erlotinib in Recurrent/Refractory Germ Cell Tumors Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors

Brief Title

Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors

Official Title

A Phase II Study To Assess The Ability Of Neoadjuvant Chemotherapy Plus/Minus Second Look Surgery To Eliminate All Measurable Disease Prior To Radiotherapy For NGGCT

Brief Summary

      RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
      dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink
      the tumor so that it is no longer present by conventional imaging and tumor markers from
      serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor
      cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of
      chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill
      more tumor cells.

      PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without
      surgery and with or without high dose chemotherapy and peripheral stem cell transplantation,
      can increase response rates prior to radiation therapy and increase progression free and
      overall surviving patients with newly diagnosed intracranial germ cell tumors.
    

Detailed Description

      OBJECTIVES:

        -  Determine the response rate of patients with non-germinomatous germ cell tumors treated
           with neoadjuvant chemotherapy.

        -  Determine the progression-free survival and overall survival of patients treated with
           neoadjuvant chemotherapy with or without second-look surgery followed by radiotherapy
           with or without autologous peripheral blood stem cell transplantation (PBSCT).

        -  Determine whether additional complete responses can be achieved after high-dose thiotepa
           and etoposide with PBSCT in patients with persistently positive markers, histological
           evidence of residual malignant elements, or unresectable residual tumors after initial
           neoadjuvant chemotherapy.

        -  Determine patterns of recurrence in patients treated with this regimen.

        -  Correlate tumor marker response with radiographic and clinical measures of response, as
           well as findings at second-look surgery in patients with radiological evidence of
           residual disease.

      OUTLINE:

        -  Induction chemotherapy:

             -  Courses 1, 3, and 5: Patients receive carboplatin IV over 1 hour on day 1 and
                etoposide IV over 1 hour on days 1-3. Beginning on day 4, patients receive
                filgrastim (G-CSF) IV or subcutaneously (SC) for 10 days or until blood counts
                recover. Courses are 3 weeks in duration.

             -  Courses 2, 4, and 6: Patients receive etoposide IV over 1 hour followed by
                ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive G-CSF
                IV or SC for 10 days or until blood counts recover. Courses are 3 weeks in
                duration.

      Patients undergo re-evaluation. Patients with a complete response (CR) go directly to
      radiotherapy. Approximately 3 weeks after completion of induction chemotherapy, all patients
      with less than a CR are encouraged to undergo second-look surgery.

      After second-look surgery, patients with a CR or a partial response (PR) go directly to
      radiotherapy. Patients with less than a PR undergo consolidation chemotherapy with peripheral
      blood stem cell rescue (PBSC) followed by radiotherapy.

        -  Consolidation chemotherapy: Patients undergo PBSC collection. Patients receive G-CSF SC
           until PBSC collection is complete. Patients then receive thiotepa IV over 3 hours
           followed by etoposide IV over 3 hours on days -5 to -3. PBSCs are reinfused on day 0.
           Beginning on day 1 and continuing until blood counts recover, patients receive G-CSF SC
           daily.

        -  Radiotherapy: All patients receive radiotherapy once daily 5 days a week for 5-6 weeks
           beginning after recovery from induction chemotherapy or second-look surgery or within 9
           weeks after PBSC reinfusion.

      Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
      for 1 year, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 80-100 patients will be accrued for this study within 36-42
      months.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response to Induction Chemotherapy

Secondary Outcome

 The Probability of Event-free Survival (EFS)

Condition

Brain Tumor

Intervention

carboplatin

Study Arms / Comparison Groups

 Radiation Therapy (CR from Induction)
Description:  Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.

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

104

Start Date

January 2004

Completion Date

February 2009

Primary Completion Date

February 2009

Eligibility Criteria

        DISEASE CHARACTERISTICS:

          -  One of the following diagnoses:

               -  Histologically confirmed intracranial non-germinomatous germ cell tumor (NGGCT)
                  of 1 of the following types:

                    -  Endodermal sinus tumor (yolk sac tumor)

                    -  Embryonal carcinoma

                    -  Choriocarcinoma

                    -  Immature teratoma and teratoma with malignant transformation

                    -  Mixed germ cell tumor

               -  Histologically confirmed germinoma with elevation of serum/CSF beta human
                  chorionic gonadotropin (HCG) levels greater than 50 mIU/mL or any serum/CSF
                  alpha-fetoprotein (AFP) levels greater than 10 ng/ml or above institutional norm

               -  Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta
                  HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above
                  institutional norm

          -  Patients with normal AFP and beta HCG < 50 mIU/mL without histologic diagnosis of a
             NGGCT or patients with pure germinoma without elevation of tumor marker are ineligible

          -  Initial diagnosis within the past 31 days

        PATIENT CHARACTERISTICS:

        Age

          -  3 to 24 at diagnosis

        Performance status

          -  No minimum performance level

        Life expectancy

          -  At least 8 weeks

        Hematopoietic

          -  Absolute neutrophil count at least 1,000/mm^3

          -  Platelet count at least 100,000/mm^3 (transfusion independent)

          -  Hemoglobin at least 10.0 g/dL (transfusion allowed)

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  ALT no greater than 2.5 times ULN

        Renal

          -  Creatinine no greater than 1.5 times ULN OR

          -  Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

        Pulmonary

          -  No assisted ventilation

        Other

          -  Seizure disorders allowed

          -  No patients in status or coma

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patient must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  Not specified

        Endocrine therapy

          -  Prior corticosteroids allowed

          -  Concurrent corticosteroids allowed

          -  Concurrent endocrine replacement therapy allowed (e.g., L-thyroxine, testosterone,
             estrogen, desmopressin acetate)

          -  No concurrent growth hormone therapy

        Radiotherapy

          -  Not specified

        Surgery

          -  More than 1 prior surgery allowed

        Other

          -  No other prior therapy for malignancy
      

Gender

All

Ages

3 Years - 24 Years

Accepts Healthy Volunteers

No

Contacts

Stewart Goldman, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT00047320

Organization ID

ACNS0122

Secondary IDs

CDR0000257664

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Stewart Goldman, MD, Study Chair, Ann & Robert H Lurie Children's Hospital of Chicago


Verification Date

January 2018