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Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Persistent or Platinum Refractory Stage III or IV Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003080
Recruitment Status : Completed
First Posted : April 14, 2004
Last Update Posted : September 15, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of sequential chemotherapy followed by peripheral stem cell transplantation in treating patients with persistent or platinum refractory stage III or stage IV ovarian cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: endocrine-modulating drug therapy Drug: melphalan Drug: mitoxantrone hydrochloride Drug: tamoxifen citrate Drug: thiotepa Procedure: peripheral blood stem cell transplantation Phase 1

Detailed Description:

OBJECTIVES: I. Establish the feasibility of treating patients with persistent or platinum refractory stage III or IV ovarian cancer with sequential high dose chemotherapy followed by peripheral blood stem cell rescue. II. Determine the maximum tolerated dose of thiotepa that can be given in such approach.

OUTLINE: This is a dose escalating study of thiotepa. Initial cytoreduction and mobilization of peripheral blood stem cells (PBSC) are conducted with FHCRC protocol 506.3 (cyclophosphamide and paclitaxel) or 506.3 (cyclophosphamide and etoposide). PBSC from syngeneic twins are collected according to FHCRC protocol 753.0. Patients then undergo leukapheresis. Patients with remaining bulky disease (greater than 2 cm) after cytoreduction/mobilization may undergo surgical debulking. High dose chemotherapy begins 30-40 days after the last chemotherapy in the cytoreduction/mobilization regimen. Patients receive mitoxantrone IV infusion over 15 minutes on days -7 and -5. Thiotepa IV is administered on days -4 and -3. Peripheral blood stem cell (PBSC) infusion occurs on day 0. 60-90 days later, melphalan IV is administered over 60 minutes on day -3. Patients undergo PBSC infusion on day 0. Patients are entered in cohorts of 3. In the absence of dose-limiting toxicity (DLT), subsequent cohorts of 3 patients each receive escalating doses of thiotepa on the same schedule. If DLT is observed in 2 of 3 patients, then the next cohort of patients each receive treatment at the next lower dose level. Once 12 patients are treated at a particular dose level, then this dose is declared the maximum tolerated dose. After engraftment following melphalan, patients receive oral tamoxifen twice a day for up to 5 years or until relapse. Patients are followed every 3 months for the first year, every 6 months for the next 4 years, then annually.

PROJECTED ACCRUAL: 20-30 patients will be accrued in 2 years.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Trial of Sequential High Dose Chemotherapy Regimens Followed by Autologous or Syngeneic Peripheral Blood Stem Cell (PBSC) Rescue in Patients With Persistent Stage III/IV Ovarian Cancer
Study Start Date : September 1996
Actual Primary Completion Date : May 2001
Actual Study Completion Date : May 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven persistent or platinum refractory stage III/IV ovarian cancer

PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/mL, unless history of Gilbert's disease SGOT or SGPT no greater than 2 times upper limit of normal Renal: Creatinine clearance at least 50 mg/mL No history of hemorrhagic cystitis Cardiovascular: No history of coronary artery disease No poorly controlled arrhythmia or myocardial infarction Left ventricle ejection fraction at least 50% Pulmonary: Diffusion capacity at least 50% Other: Not pregnant HIV negative No second malignancy in the last 5 years except basal carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No history of allergy to any chemotherapy drugs Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003080

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United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
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Study Chair: Leona A. Holmberg, MD, PhD Fred Hutchinson Cancer Research Center

Layout table for additonal information Identifier: NCT00003080     History of Changes
Other Study ID Numbers: 1144.00
CDR0000065775 ( Registry Identifier: PDQ )
First Posted: April 14, 2004    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010
Keywords provided by Fred Hutchinson Cancer Research Center:
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists