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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00002943
First received: November 1, 1999
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Extragonadal Germ Cell Tumor
Ovarian Cancer
Testicular Germ Cell Tumor
Unspecified Adult Solid Tumor, Protocol Specific
Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide
Procedure: autologous bone marrow transplantation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Bone Marrow Transplantation for Relapsed and Refractory Germ Cell Cancer: A Phase II Pilot Study

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • To investigate the response rate High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation [ Time Frame: 45 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • evaluate toxicity of High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation [ Time Frame: 45 days ]

Enrollment: 11
Study Start Date: February 1993
Study Completion Date: August 2007
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002943

Locations
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Study Chair: David D. Hurd, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00002943     History of Changes
Other Study ID Numbers: CDR0000065392, CCCWFU-95193, NCI-G97-1146
Study First Received: November 1, 1999
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
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

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Germ Cell and Embryonal
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Cyclophosphamide
Etoposide phosphate
Etoposide
Carboplatin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 16, 2014