506U78 in Treating Patients With Lymphoma

NCT00005080 | Completed Phase 2

• 4 other identifiers: NCI-2012-02324CALGB-59901U10CA031946CDR0000067687
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die

Conditions

Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Small Intestine Lymphoma; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage I Mycosis Fungoides/Sezary Syndrome; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Mycosis Fungoides/Sezary Syndrome; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage III Mycosis Fungoides/Sezary Syndrome; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome

Outcome Measures

Primary Outcomes (3)

• Remission rate (complete and partial remission)

  Up to 2 years

• Remission duration

  Remission duration will be estimated using the method of Kaplan Meier.

  From the time of first reported complete or partial response (later confirmed) until time of documented relapse, assessed up to 2 years

• Toxicity as assessed by the NCI Common Toxicity Criteria (CTC) version 2.0

  Up to 2 years

Study Arms (1)

Nelarabine

EXPERIMENTAL

Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to 8 courses of therapy.

Drug: nelarabine

Interventions

nelarabine DRUG

Given IV

Also known as: 506U78, Arranon, GW506U78

Nelarabine

Eligibility Criteria

• Age: Up to 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented cutaneous T-cell lymphoma (CTCL) or noncutaneous peripheral T-cell lymphoma (PTCL) (needle aspirate or core biopsy of tissue or marrow as the sole means of diagnosis is not acceptable), confirmed by immunophenotyping, including:
• Mycosis fungoides/Sezary syndrome
• Peripheral T-Cell lymphomas (medium, mixed medium-large, large cell)
• Variants of peripheral T-Cell lymphoma
• Angioimmunoblastic T-Cell lymphoma (AILD); angiocentric lymphoma; intestinal T-Cell Lymphoma; adult T-Cell lymphoma/leukemia (ATLL); anaplastic Large Cell (CD30+) lymphoma, T-cell type Failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible; Note: patients diagnosed more than one year prior to entry on this protocol must have a repeat lymph node biopsy. In the event of rapid tumor growth, rising LDH, or the onset of B symptoms in a period of time less than one year a rebiopsy is also required
• Biopsy and immunophenotyping should be performed to document relapse after prior treatment
• CTCL patients may have received one prior course of single-agent systemic chemotherapy for CTCL, but may not have received a multi-agent chemotherapy regimen; patients may have received prior local, topical, radiation- or electron beam-based, or chemotherapy-based treatment; examples of the latter would include, but not be limited to, cytokines such as interferon, retinoids, monoclonal antibodies, and fusion toxins
• PTCL patients may have failed only one or two prior treatment regimens (one of which may include peripheral stem cell transplantation)
• Patients must have measurable disease; patients with CTCL must have skin lesions which are measurable; whenever CT is specified, it should be understood that MRI may be substituted as long as the measurements for tumor response are made on two successive studies employing the same procedure
• The following lesions are not considered measurable:
• Barium studies
• Ascites or pleural effusion
• Bony disease (lesions if present should be noted)
• Bone marrow
• No CNS lymphoma requiring intrathecal or craniospinal radiation therapy

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Lymphoma, Large-Cell, Anaplastic; Immunoblastic Lymphadenopathy; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

nelarabine

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphadenopathy; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Study Officials

• Myron Czuczman

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2000
• First Posted: April 19, 2004
• Study Start: May 1, 2000
• Primary Completion: January 1, 2006
• Last Updated: January 16, 2013

Record last verified: 2013-01

Locations

US (1)