High-Dose Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Poor-Prognosis Breast Cancer

NCT00002509 | Completed Phase 1

• 3 other identifiers: CDR0000078064TUHSC-1992NCI-V92-0205
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining peripheral stem cell transplantation with combinations of drugs may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of high-dose combination chemotherapy followed by peripheral stem cell transplantation or autologous bone marrow transplantation in women with stage II breast cancer with eight or more positive axillary lymph nodes and in women with stage III or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer

Interventions

filgrastim BIOLOGICAL

carboplatin DRUG

cyclophosphamide DRUG

etoposide DRUG

mesna DRUG

autologous bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: Histologically confirmed invasive (stage II-IV) carcinoma of the breast 8 or more positive axillary nodes required for stage II disease Chemotherapy-responsive disease required of patients with measurable or evaluable disease Partial or complete response to 3 courses of standard cyclophosphamide/doxorubicin/fluorouracil (CAF) or, for patients who have had CAF, cyclophosphamide/methotrexate/fluorouracil (CMF) 3-month course of standard mitomycin/vinblastine or paclitaxel acceptable in patients clearly resistant to CAF or CMF Visceral response despite progression in bone will be considered on an individual basis Patients with no evidence of disease may be entered without evidence of a chemotherapy response Resectable disease must be surgically removed prior to transplantation Hormone receptor status: If estrogen-receptor positive, prior failure with at least 1 hormonal manipulation required unless patient is premenopausal or has rapidly progressing visceral disease No more than 20% of marrow involved with tumor PATIENT CHARACTERISTICS: Age: 15 to 60 Sex: Women only Menopausal status: Not specified Performance status: Karnofsky 80%-100% Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL AST less than 2 times normal Albumin at least 3.0 g/dL Renal: Creatinine less than 1.8 mg/dL BUN less than 20 mg/dL Cardiovascular: Left ventricular ejection fraction at least 55% Pulmonary: DLCO, FEV1, and FVC at least 50% of predicted pO2 at least 70 mm Hg on room air Other: No serious psychiatric, neurologic, or medical illness that would compromise the safety of a bone marrow transplant Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics Radiotherapy: No prior chest irradiation other than to locally involved lymph nodes Surgery: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Temple University: lead
• Fox Chase Cancer Center: collaborator

Study Sites (1)

Temple University Cancer Center

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (1)

• Klumpp TR, Goldberg SL, Mangan KF, et al.: High dose cyclophosphamide, etoposide, and carboplatin (CEC) with autologous stem cell rescue for chemosensitive metastatic and high risk breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 13: A-245, 111, 1994.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Filgrastim; Carboplatin; Cyclophosphamide; Etoposide; Mesna; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Thomas R. Klumpp, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: August 31, 2004
• Study Start: November 1, 1991
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: October 1, 2010

Record last verified: 2010-09

Locations

US (1)