Completed

High Dose Carboplatin, Etoposide, Cyclophosphamide and Autologous Bone Marrow Transplantation for Relapsed and Refractory Germ Cell Cancer: A Phase II Pilot Study

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What is being tested

carboplatin

+ cyclophosphamide

+ etoposide

DrugProcedure
Who is being recruted

Urogenital Diseases+17

+ Genital Diseases

+ Adnexal Diseases

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 1993
See protocol details

Summary

Principal SponsorWake Forest University Health Sciences
Last updated: August 10, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1993

Actual date on which the first participant was enrolled.

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.

NCT00002943
Principal SponsorWake Forest University Health Sciences
Last updated: August 10, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

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

11 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Diseases, MaleGenital Neoplasms, FemaleGenital Neoplasms, MaleGonadal DisordersNeoplasmsNeoplasms by SiteOvarian DiseasesTesticular DiseasesUrogenital NeoplasmsFemale Urogenital DiseasesMale Urogenital DiseasesOvarian NeoplasmsTesticular Neoplasms

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, United StatesOpen Comprehensive Cancer Center at Wake Forest University in Google Maps
CompletedOne Study Center