Phase I Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Plus GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor) Plus Dose Escalation of IL-3 (Interleukin-3) in Metastatic Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Phase I Trial of FLAC (5-Fluorouracil, Leucovorin, Adriamycin, Cytoxan) Plus GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor) Plus Dose Escalation of IL-3 (Interleukin-3) in Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001269
• Other study ID #: 910121
• Secondary ID: 91-C-0121
• Status: Completed
• Phase: Phase 1
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: May 1991
• Est. completion date: February 2001

Study information

• Verified date: April 2000
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This is a phase I study to determine the maximal tolerated dose of IL-3 given alone or sequentially with GM-CSF following FLAC chemotherapy in metastatic breast cancer patients.

Description:

Phase I study to determine the maximal tolerated dose of IL-3 given alone or sequentially with GM-CSF following FLAC chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Patients with Stage IV (metastatic) breast cancer are eligible who have a histologically-proven diagnosis. Measurable disease is not a prerequisite. Patients with Stage III disease or Stage ll with 7 or more nodes positive are eligible.

Patients who have had prior adjuvant chemotherapy and/or hormonal therapy are eligible providing the regimen did not include adriamycin. Patients who have had prior radiation therapy may be eligible providing there was not extensive radiation to the cardiac area or to greater than 20% of the bone marrow.

Patients who have received greater than 360mg/m2 of adriamycin as adjuvant therapy are ineligible.

Patient must be previously untreated with chemotherapy for metastatic disease.

There must be no history of previous malignancy except for cured non-melanoma skin cancer (basal or squamous cell carcinoma), cervical cancer in situ, or a past malignancy that has been inactive for over 5 years.

Performance status (Karnofsky scale) must be greater than 70; ECOG 0-2.

Absolute granulocyte count greater than 1500/mm3 and platelet count greater than 100,000/mm3.

Liver function tests (SCOT, Alk, Phosph., and T. Bili) should be less than 1.5 time the upper limits of normal. Serum creatinine should be less than 1.7 or creatinine clearance should be greater than 45 ml/min unless these abnormalities are due to tumor involvement.

The patient must be able to give an informed consent, and to return to NCI for treatment and adequate follow-up for the period the protocol requires.

No pregnant patients may be entered on this study; all patients should be informed about the need for contraception.

Patients must be greater than or equal to 18 years of age.

No patients who are poor medical or psychiatric risks because of nonmalignant systemic disease which would preclude them from being subjected to any treatments in this protocol.

No patients with a history of cardiac disease must have a normal ejection fraction by MUGA Scan and have no angina. Patients who have received prior adriamycin must have a LVEF greater than 45%.

No history of CNS metastasis, or known seizure disorder.

No allergy to any study medication.

No pregnant or lactacting women.

No patients requiring ongoing therapy for asthma.

No patients with bleeding disorders.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• IL-3

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Antman K, Gale RP. Advanced breast cancer: high-dose chemotherapy and bone marrow autotransplants. Ann Intern Med. 1988 Apr;108(4):570-4. Review. — View Citation

Clark SC, Kamen R. The human hematopoietic colony-stimulating factors. Science. 1987 Jun 5;236(4806):1229-37. Review. — View Citation

Metcalf D, Begley CG, Johnson GR, Nicola NA, Vadas MA, Lopez AF, Williamson DJ, Wong GG, Clark SC, Wang EA. Biologic properties in vitro of a recombinant human granulocyte-macrophage colony-stimulating factor. Blood. 1986 Jan;67(1):37-45. — View Citation