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

Primary Purpose

Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
cyclophosphamide
etoposide
autologous bone marrow transplantation
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extragonadal Germ Cell Tumor focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Center at Wake Forest University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 1999
Last Updated
August 8, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002943
Brief Title
Carboplatin, Etoposide, Cyclophosphamide, and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer
Official Title
High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Bone Marrow Transplantation for Relapsed and Refractory Germ Cell Cancer: A Phase II Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 1993 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
OBJECTIVES: Investigate the response rate, duration of response, survival, time to marrow reconstitution, and toxicity of two successive cycles of high dose carboplatin, etoposide, and cyclophosphamide chemotherapy and ABMT in patients with relapsed and refractory germ cell cancer or other chemotherapy-sensitive solid tumors. Further define the pretransplant characteristics of patients and their disease that might influence the outcome of this therapy. OUTLINE: Patients receive carboplatin and etoposide for 5 days and cyclophosphamide for 2 days prior to ABMT. At day 60 following ABMT, if the patient has a complete response (CR) or partial response (PR) and nonhematologic toxicity is no greater than grade 2, a second ABMT course is given when hematologic parameters and other criteria are acceptable. If there is no CR or PR and/or nonhematologic toxicity exceeds grade 2, a second ABMT is not given. After ABMT patients are followed until disease progression or death. PROJECTED ACCRUAL: Ten patients will be accrued for this pilot study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
etoposide
Intervention Type
Procedure
Intervention Name(s)
autologous bone marrow transplantation
Primary Outcome Measure Information:
Title
To investigate the response rate High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation
Time Frame
45 days
Secondary Outcome Measure Information:
Title
evaluate toxicity of High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation
Time Frame
45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David D. Hurd, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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