Know Cancer

forgot password

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

Phase 2
18 Years
Not Enrolling
Extragonadal Germ Cell Tumor, Ovarian Cancer, Testicular Germ Cell Tumor, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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


- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Greater than 2 months


- Platelet count at least 100,000/mm3

- Neutrophil count at least 1,500/mm3


- Bilirubin, alkaline phosphatase, SGOT, and SGPT less than 3 times upper limit of
normal, unless due to disease


- Creatinine less than 1.5 times upper limit of normal

- Creatinine clearance at least 60 ml/min


- Ventricular ejection fraction at least 45%

- No uncontrolled or severe cardiovascular disease including recent myocardial
infarction, congestive heart failure, angina, life-threatening arrhythmia, or


- DLCO and spirometry greater than 50% of predicted


- 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


Biologic therapy:

- Not specified


- No prior high-dose carboplatin, etoposide, or cyclophosphamide

Endocrine therapy:

- Not specified


- Not specified


- Not specified

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

45 days

Safety Issue:


Principal Investigator

David D. Hurd, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Institutional Review Board

Study ID:




Start Date:

February 1993

Completion Date:

August 2007

Related Keywords:

  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
  • Unspecified Adult Solid Tumor, Protocol Specific
  • 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
  • Ovarian Neoplasms
  • Neoplasms, Germ Cell and Embryonal



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