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

August 8, 2018 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-1082
        • Comprehensive Cancer Center at Wake Forest University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To investigate the response rate High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation
Time Frame: 45 days
45 days

Secondary Outcome Measures

Outcome Measure
Time Frame
evaluate toxicity of High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Transplantation
Time Frame: 45 days
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David D. Hurd, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 1993

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

August 10, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065392
  • CCCWFU-95193
  • NCI-G97-1146

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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