Phase 2
N=48
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer
Brain and Central Nervous System Tumors · Extragonadal Germ Cell Tumor · Ovarian Cancer · Teratoma · Testicular Germ Cell Tumor
Bottom Line
View on ClinicalTrials.gov: NCT00002931 ↗Enrolled (actual)
48
Serious AEs
2.1%
Results posted
Jan 2017
Primary outcome: Primary: Progression-free Survival — 11.8 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- filgrastim (Biological); carboplatin (Drug); etoposide (Drug); ifosfamide (Drug); paclitaxel (Drug); autologous bone marrow transplantation (Procedure); bone marrow ablation with stem cell support (Procedure)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- City of Hope Medical Center
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
11.8 | — |
| PRIMARY Toxic Effects |
4; 6; 10; 5; 1; 3 | — |
| SECONDARY Overall Survival |
21.7 | — |
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bone marrow transplantation or peripheral stem cell transplantation works in treating patients with relapsed germ cell cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Evaluable germ cell cancer (measurable by radiographic study and/or serum tumor marker elevation) and not curable by standard salvage therapy OR viable cancer on resection of post-chemotherapy residual masses in either intermediate or high risk category
- Bidimensionally measurable disease with measurements performed within 21 days of study entry
- Tumor marker (alpha-fetoprotein, lactate dehydrogenase, beta-human chorionic gonadotropin) studies performed within 7 days prior to study entry
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 120,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic:
- Bilirubin no greater than 1.6 mg/dL
- SGOT and SGPT no greater than 2 times upper limit of normal (ULN)
- No active hepatitis or cirrhosis
Renal:
- Creatinine clearance at least 70 mL/min
Cardiovascular:
- Ejection fraction (MUGA or echocardiogram) normal
- No EKG evidence of active cardiac disease (arrhythmias, ischemia) which would contraindicate etoposide and paclitaxel study treatment
Pulmonary:
- PaO\_2 at least 70 mm Hg
- FEV\_1 at least 2 L or 75%
- No history of bleomycin associated or serious lung disease
Neurologic:
- No steroid or glucocorticoid treatment for patients with CNS metastatic disease; at least 1 month with stable post-radiotherapy neurological status and seizure free; if prior seizures, at least 1 month with therapeutic anticonvulsant levels prior to study
- Prior peripheral neuropathy requires consultation with principal investigator
Other:
- No significant active medical illness precluding study or survival
- Not HIV positive
- No prior malignancy within past 5 years except for adequately treated basal cell or squamous cell skin cancer
- No prior hematologic malignancies
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior bone marrow or stem cell rescue with high-dose chemotherapy
Chemotherapy:
- Prior chemotherapy allowed, excluding high-dose therapy with bone marrow or stem cell rescue
- No prior paclitaxel
Endocrine therapy:
- Not specified
Radiotherapy:
- No concurrent radiotherapy during study
Surgery:
- Recovered from prior surgery
Data sourced from ClinicalTrials.gov (NCT00002931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.