Carboplatin, Etoposide, Cyclophosphamide, and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer

NCT00002943 | Completed Phase 2 FDA Drug

• 3 other identifiers: CDR0000065392CCCWFU-95193NCI-G97-1146
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation may help the body kill more tumor cells. PURPOSE: Phase II trial to study the effects of high doses of carboplatin, etoposide, and cyclophosphamide followed by autologous bone marrow transplantation in patients with relapsed or refractory germ cell cancer and other chemotherapy-sensitive solid tumors.

Conditions

Extragonadal Germ Cell Tumor; Ovarian Cancer; Testicular Germ Cell Tumor; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

stage III malignant testicular germ cell tumor; recurrent malignant testicular germ cell tumor; unspecified adult solid tumor, protocol specific; stage III ovarian germ cell tumor; stage IV ovarian germ cell tumor; recurrent ovarian germ cell tumor; extragonadal germ cell tumor

Outcome Measures

Primary Outcomes (1)

• To investigate the response rate High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation

  45 days

Secondary Outcomes (1)

• evaluate toxicity of High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation

  45 days

Interventions

carboplatin DRUG

cyclophosphamide DRUG

etoposide DRUG

autologous bone marrow transplantation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed, measurable germ cell cancer relapsed or refractory after frontline therapy with cisplatin and etoposide-containing chemotherapy * Other chemotherapy-sensitive solid tumors eligible (as of 06/11/97) * Possibility of residual mass representing benign teratoma must be excluded * Elevated serum tumor markers only are acceptable if possibilities of false-positive serum tumor markers or sanctuary disease have been excluded * Also eligible after two to four cycles of conventional dose salvage chemotherapy, regardless of response * No CNS or bone marrow involvement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Greater than 2 months Hematopoietic: * Platelet count at least 100,000/mm3 * Neutrophil count at least 1,500/mm3 Hepatic: * Bilirubin, alkaline phosphatase, SGOT, and SGPT less than 3 times upper limit of normal, unless due to disease Renal: * Creatinine less than 1.5 times upper limit of normal * Creatinine clearance at least 60 ml/min Cardiovascular: * Ventricular ejection fraction at least 45% * No uncontrolled or severe cardiovascular disease including recent myocardial infarction, congestive heart failure, angina, life-threatening arrhythmia, or hypertension Pulmonary: * DLCO and spirometry greater than 50% of predicted Other: * Not HIV positive * No active peptic ulcer * No uncontrolled diabetes mellitus * No active infection * No previous or concomitant malignancy other than curatively treated basal or squamous cell carcinoma of the skin * Not HBsAG positive PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior high-dose carboplatin, etoposide, or cyclophosphamide Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Testicular Germ Cell Tumor; Testicular Neoplasms

Interventions

Carboplatin; Cyclophosphamide; Etoposide

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• David D. Hurd, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: February 1, 1993
• Primary Completion: October 1, 2003
• Study Completion: August 1, 2007
• Last Updated: August 10, 2018

Record last verified: 2018-08

Locations

US (1)