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A Phase I Trial of Melphalan and Thiotepa Followed by Autologous or Syngeneic Peripheral Blood Stem Cell (PBSC) Rescue in Patients With a Complete Response Following Standard Therapy for Stage III/IV Epithelial Ovarian Cancer


Phase 1
18 Years
60 Years
Not Enrolling
Female
Ovarian Cancer

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Trial Information

A Phase I Trial of Melphalan and Thiotepa Followed by Autologous or Syngeneic Peripheral Blood Stem Cell (PBSC) Rescue in Patients With a Complete Response Following Standard Therapy for Stage III/IV Epithelial Ovarian Cancer


OBJECTIVES: I. Assess the toxic effects of combined high dose melphalan and thiotepa
chemotherapy followed by stem cell rescue in patients with stage III or IV ovarian
epithelial cancer in complete remission. II. Determine the maximum tolerated dose of
thiotepa that can be given with melphalan in these patients. III. Evaluate the interpatient
blood level variability and pharmacokinetics of melphalan given intravenously.

OUTLINE: This is a dose escalation study of thiotepa. Patients receive cytoreduction and
mobilization of peripheral blood stem cells (PBSC) with filgrastim (G-CSF) and
cyclophosphamide/paclitaxel, cyclophosphamide/etoposide or
cyclophosphamide/etoposide/cisplatin within 30-90 days of last dose of standard therapy.
PBSC are then collected. Patients then receive melphalan IV over 30 minutes on days -6 and
-5 and thiotepa IV over 2 hours on days -4 and -3. PBSC are reinfused on day 0. G-CSF is
administered on days 0-21. Cohorts of 5-15 patients each receive escalating doses of
thiotepa until the maximum tolerated dose (MTD) is reached. The MTD is determined as the
dose at which 2-5 of 4-15 patients experience dose limiting toxicity. Patients are followed
at 100 days, then at 6, 12, and 24 months.

PROJECTED ACCRUAL: A total of 30-45 patients will be accrued for this study over 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed stage III/IV ovarian epithelial cancer
in first or second clinical complete remission after receiving a minimum of 4-10 courses
of chemotherapy consisting of paclitaxel and either cisplatin or carboplatin Ovarian
epithelial cancer of following histologic types: Serous adenocarcinoma Mucinous
adenocarcinoma Clear cell adenocarcinoma Transitional cell Adenocarcinoma N.O.S.
Endometrioid adenocarcinoma Undifferentiated carcinoma Mixed epithelial carcinoma
Malignant Brenner's Tumor Remission stability maintained for at least 4 weeks Protocol
therapy must begin 30-90 days after last dose of standard therapy No active pleural or
pericardial effusion No prior/concurrent brain metastasis or carcinoid meningitis

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 1.5
times the upper limit of normal (ULN) SGOT or SGPT less than 2.0 times ULN Albumin greater
than 2.0 g/dL Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: Ejection
fraction greater than 45% by MUGA Pulmonary: If history of smoking or abnormal lung
function, Diffusion capacity greater than 50% (corrected) A-a gradient less than 20 Other:
No history of hemorrhagic cystitis No second malignancy within the last 5 years except
basal cell skin cancer HIV negative No chronic active hepatitis B No hepatitis C No
history of Aspergillus infection

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplant Chemotherapy:
Prior chemotherapy consisting of paclitaxel and either cisplatin or carboplatin Endocrine
therapy: Not specified Radiotherapy: No prior radiation therapy for malignancy (excluding
chest wall radiation therapy for breast cancer) Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Leona A. Holmberg, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1181.00

NCT ID:

NCT00002977

Start Date:

January 1997

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • ovarian undifferentiated adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • Brenner tumor
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109