Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Completed	16 and over	NCI	CTEP-TRC-9701 CWRU-TRC-1499, NCT00003837, TRC-9701

Special Category: Treatment Referral Center (TRC) trial

Objectives

1. Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority.
2. Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients.
3. Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
  • Tumor cells should exhibit phenotypic characteristics of these diseases
• No CNS involvement requiring intrathecal or craniospinal radiotherapy
• Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority

Prior/Concurrent Therapy:

Biologic therapy:

• Prior bone marrow transplantation allowed
• No concurrent allogeneic bone marrow transplantation

Chemotherapy:

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
• No prior 506U78

Endocrine therapy:

• No concurrent systemic steroid therapy

Radiotherapy:

• See Disease Characteristics
• Prior radiotherapy allowed

Surgery:

• Not specified

Other:

• No other concurrent investigational therapy
• No concurrent treatment for seizures

Patient Characteristics:

Age:

• 16 and over

Performance status:

• ECOG 0-3

  OR

• Karnofsky 40-100%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

Renal:

• Creatinine no greater than 1.5 mg/dL

  OR

• Creatinine clearance at least 50 mL/min

Other:

• No neuropathy grade 2 or higher
• No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy
• No active seizure disorder
• No active infection
• No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix
• Not pregnant or nursing
• Fertile patients must use effective contraception

Expected Enrollment

A minimum of 25 patients will be accrued for this study.

Outcomes

Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority

Toxicity
Antitumor efficacy as defined by the rate of complete hematologic responses

Outline

Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for one year and then every 6 months until death.

Trial Contact Information

Trial Lead Organizations

NCI - Cancer Therapy Evaluation Program

Anthony Murgo, MD, Protocol chair(Contact information may not be current)		Ph: 301-496-5223

Registry Information
Official Title		Compound 506U78 (NSC 686673) in Patients with Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
Trial Start Date		1999-09-01
Registered in ClinicalTrials.gov		NCT00003837
Date Submitted to PDQ		1999-03-24
Information Last Verified		2005-12-16

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