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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002931
First Posted: January 27, 2003
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center
  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: None (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:
  • Progression-free Survival [ Time Frame: Until disease progression, up to 5 years. ]
    Estimated using the product-limit method of Kaplan and Meier. Progression is defined as an increase o any radiologically measureable tumor by greater than 25% or a greater than 10% increase of elevated tumor markers.

  • Toxic Effects [ Time Frame: From date of randomization until death of any cause, assessed up to 12 weeks ]
    Number of Participants with Grade 3 and 4 Adverse Events Related to Protocol-based Therapy


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Until death from any cause, up to 5 years. ]
    Estimated using the product-limit method of Kaplan and Meier.


Enrollment: 48
Study Start Date: February 1997
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HD Chemo and Auto Stem Cells 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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Study Chair: Sumanta Pal, MD City of Hope Medical Center
  More Information

Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00002931     History of Changes
Other Study ID Numbers: 96126
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-96126
NCI-G97-1136
CDR0000065365 ( Registry Identifier: NCI PDQ )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: November 4, 2016
Results First Posted: January 4, 2017
Last Update Posted: February 23, 2017
Last Verified: January 2017

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
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Teratoma
Testicular Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Nervous System Diseases
Endocrine Gland Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Carboplatin
Etoposide
Ifosfamide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents