506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-Cell Lymphoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: nelarabine (Drug); chemotherapy (Procedure)
Phase: Phase 2
Status: Completed
Sponsored by: M.D. Anderson Cancer Center Official(s) and/or principal investigator(s):
Andre Goy, MD, Study Chair, Affiliation: M.D. Anderson Cancer Center
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma.
Clinical Details
Official title:
Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma
Study design: Interventional, Treatment
Detailed description:
OBJECTIVES:
* Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78.
* Determine the toxicity of this drug in these patients
* Study the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3 years.
Eligibility
Minimum age: 16 Years.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma
- Large cell transformation of cutaneous T-cell lymphoma allowed
* No active CNS disease
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,000/mm^3*
* Platelet count at least 100,000/mm^3* NOTE: *Unless attributable to marrow or splenic involvement by lymphoma
Hepatic:
* Bilirubin no greater than 1. 5 times upper limit of normal (ULN)
* SGPT no greater than 2. 5 times ULN
Renal:
* Creatinine clearance greater than 50 mL/min
Cardiovascular
* No history of symptomatic cardiac dysfunction
* No history of pericardial effusion
Other:
* HIV negative
* No grade 2 or greater sensory or motor neuropathy
* No history of seizures
* No other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin of carcinoma in situ of the cervix
* No medical, psychiatric, or social condition that would preclude study
* No other concurrent serious illness or active infection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior stem cell or bone marrow transplantation (BMT)
* No more than 1 prior immunotherapy regimen
* No more than 3 prior systemic regimens with denileukin diftitox
* At least 3 weeks since prior biologic therapy
* No concurrent BMT
Chemotherapy:
* No prior 506U78
* No more than 3 prior systemic chemotherapy regimens comprising any of the following:
- Oral methotrexate
- Topical mechlorethamine
* At least 3 weeks since prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* At least 3 weeks since prior anticancer endocrine therapy
* No concurrent topical or systemic steroids
Radiotherapy:
* At least 3 weeks since prior radiotherapy
* No more than 3 prior systemic regimens comprising any of the following:
- Total skin electron beam therapy
- Spot radiotherapy
Surgery:
* Not specified
Other:
* No more than 3 prior systemic regimens comprising any of the following:
- Oral retinoids
- Ultraviolet therapy (PUVA)
* At least 3 weeks since prior anticancer therapy
Locations and Contacts
CCOP - M.D. Anderson Research Base, Houston, Texas 77030-4009, United States
University of Texas - MD Anderson Cancer Center, Houston, Texas 77030-4009, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: September 18, 2007
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