BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase I/II trial to study the effectiveness BCX-1777 in treating patients who have refractory cutaneous T-cell lymphoma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioCryst Pharmaceuticals

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed cutaneous T-cell lymphoma (CTCL)

• Any stage except IA patch only

• Previously treated according to 1 of the following:

• Stage IA plaque, IB, or IIA:

• At least 4 prior conventional and/or experimental regimens (topical or systemic, including psoralen-ultraviolet light [PUVA] and systemic corticosteroids)

• Stage IIB, III, or IV:

• At least 1 prior systemic regimen (systemic corticosteroids and PUVA do not count as systemic regimens for this purpose) NOTE: Repeated use of the same regimen is considered one regimen

• Measurable disease

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-3

Life expectancy

• At least 3 months

Hematopoietic

• Granulocyte count at least 2,000/mm^3

• Platelet count at least 75,000/mm^3

• Hemoglobin at least 10.0 g/dL

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome)

• ALT no greater than 2 times ULN

• Alkaline phosphatase no greater than 2 times ULN

• No hepatitis B or C

Renal

• Creatinine clearance at least 45 mL/min

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• HIV negative

• Human T-cell leukemia virus type 1 (HTLV-1) negative

• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No other illness that would limit study participation

• No active serious infection not controlled by antibiotics

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent anticancer antibody therapy

• No concurrent anticancer immunotherapy

• No concurrent anticancer gene therapy

• No concurrent anticancer vaccine therapy

• No concurrent anticancer angiogenesis inhibitors

• No concurrent sargramostim (GM-CSF)

• No concurrent filgrastim (G-CSF) during course 1 of therapy

Chemotherapy

• More than 21 days since prior chemotherapy unless fully recovered

• No concurrent anticancer chemotherapy

Endocrine therapy

• See Disease Characteristics

• More than 2 weeks since prior topical corticosteroids

• No concurrent anticancer hormonal therapy

Radiotherapy

• More than 2 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• More than 2 weeks since prior antineoplastic therapy

• More than 21 days since prior investigational agents unless fully recovered

• No concurrent citrate-blood products within 30 minutes before or after study treatment

• No concurrent anticancer matrix metalloprotease inhibitors

• No other concurrent anti-CTCL therapy

• No concurrent use of tanning beds

• No other concurrent investigational agents