Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00002931
First received: November 1, 1999
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Extragonadal Germ Cell Tumor
Ovarian Cancer
Teratoma
Testicular Germ Cell Tumor
Biological: filgrastim
Drug: carboplatin
Drug: etoposide
Drug: ifosfamide
Drug: paclitaxel
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tandem High-Dose Chemotherapy With Autologous Stem Cell Rescue for Poor-Prognosis Germ Cell Cancer

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • Antitumor activity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Toxic effects [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: February 1997
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: filgrastim
    5 ug/kg bid beginning 4 days prior to and continuing through stem cell collection.
    Drug: carboplatin
    AUC=7, daily X 3
    Drug: etoposide
    20 mg/kg by 2 hours infusion daily X 3
    Drug: ifosfamide
    3 gm/m2 IV over 30 minutes X 3 days
    Drug: paclitaxel
    425 mg/m2 as 24 hour continuous infusion
    Procedure: autologous bone marrow transplantation
    Given in two divided infusions on day -2 and day 0
    Procedure: bone marrow ablation with stem cell support
    Two cycles of high dose chemotherapy followed by stem cell reinfusion
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002931

Locations
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
Investigators
Study Chair: Sumanta Pal, MD City of Hope Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00002931     History of Changes
Other Study ID Numbers: 96126, P30CA033572, CHNMC-96126, NCI-G97-1136, CDR0000065365
Study First Received: November 1, 1999
Last Updated: December 16, 2013
Health Authority: United States: Federal Government

Keywords provided by City of Hope Medical Center:
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

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Testicular Neoplasms
Teratoma
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Nervous System Diseases
Genital Neoplasms, Male
Genital Diseases, Male
Testicular Diseases

ClinicalTrials.gov processed this record on September 18, 2014