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Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer


Phase 2
16 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor

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Trial Information

Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer


OBJECTIVES:

- Estimate the antitumor activity of 2 courses of paclitaxel and carboplatin regimens
with autologous stem cell rescue in patients with relapsed germ cell cancer.

- Evaluate the toxic effects of paclitaxel, carboplatin and etoposide (VP-16) with stem
cell support followed by paclitaxel, carboplatin and ifosfamide with stem cell support
in these patients.

OUTLINE: Patients receive filgrastim (G-CSF) SC or IV 4 days prior to peripheral blood stem
cells (PBSC) apheresis. Autologous bone marrow harvest is performed when adequate stem cells
cannot be collected.

Patients then receive course 1 of high-dose chemotherapy beginning on day -7 with paclitaxel
IV over 24 hours. On days -6 to -4, patients receive etoposide IV over 2 hours and
carboplatin (CBDCA) IV over 30 minutes 3 times daily. Following a 2 or 3 week recovery, a
second course of chemotherapy begins on day -7, consisting of paclitaxel IV over 24 hours,
then CBDCA and ifosfamide on days -6 to -4.

Reinfusion of PBSC and marrow begins on day -2 in both course 1 and 2. In addition, G-CSF IV
is given twice a day until 3 consecutive postnadir days of granulocytes of at least
1000/mm^3 are maintained. On day 0, stem cells with or without bone marrow product are again
administered.

Surgery may be performed after course 2 if indicated.

PROJECTED ACCRUAL: The expected accrual rate is 12 patients per year over 2 years.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Antitumor activity

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Sumanta Pal, MD

Investigator Role:

Study Chair

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Federal Government

Study ID:

96126

NCT ID:

NCT00002931

Start Date:

February 1997

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Teratoma
  • Testicular Germ Cell Tumor
  • recurrent malignant testicular germ cell tumor
  • testicular seminoma
  • testicular embryonal carcinoma
  • testicular choriocarcinoma
  • testicular yolk sac tumor
  • testicular embryonal carcinoma and teratoma
  • testicular embryonal carcinoma and teratoma with seminoma
  • testicular embryonal carcinoma and yolk sac tumor
  • testicular embryonal carcinoma and yolk sac tumor with seminoma
  • testicular embryonal carcinoma and seminoma
  • testicular yolk sac tumor and teratoma
  • testicular yolk sac tumor and teratoma with seminoma
  • testicular choriocarcinoma and yolk sac tumor
  • testicular choriocarcinoma and embryonal carcinoma
  • testicular choriocarcinoma and teratoma
  • testicular choriocarcinoma and seminoma
  • recurrent ovarian germ cell tumor
  • recurrent extragonadal non-seminomatous germ cell tumor
  • recurrent extragonadal seminoma
  • recurrent extragonadal germ cell tumor
  • adult teratoma
  • testicular immature teratoma
  • testicular mature teratoma
  • ovarian immature teratoma
  • ovarian mature teratoma
  • ovarian monodermal and highly specialized teratoma
  • stage III malignant testicular germ cell tumor
  • stage IV ovarian germ cell tumor
  • stage IV extragonadal non-seminomatous germ cell tumor
  • stage IV extragonadal seminoma
  • adult central nervous system germ cell tumor
  • Nervous System Neoplasms
  • Ovarian Neoplasms
  • Teratoma
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010