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

November 1, 1999
July 12, 2012
February 1993
October 2003   (final data collection date for primary outcome measure)
To investigate the response rate High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation [ Time Frame: 45 days ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00002943 on ClinicalTrials.gov Archive Site
evaluate toxicity of High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation [ Time Frame: 45 days ]
Not Provided
Not Provided
Not Provided
 
Carboplatin, Etoposide, Cyclophosphamide, and Autologous Bone Marrow Transplantation in Patients With Relapsed or Refractory Cancer
High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Bone Marrow Transplantation for Relapsed and Refractory Germ Cell Cancer: A Phase II Pilot Study

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
August 2007
October 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002943
CDR0000065392, CCCWFU-95193, NCI-G97-1146
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: David D. Hurd, MD Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP