Trials / Completed
CompletedNCT00005080
506U78 in Treating Patients With Lymphoma
A Phase II Study of 506U78 in Patients With Previously Systemically Untreated Cutaneous T-cell Lymphoma (CTCL) or With Refractory or Relapsed Non-cutaneous Peripheral T-cell Lymphoma (PTCL)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 69 Years
- Healthy volunteers
- Not accepted
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
Detailed description
PRIMARY OBJECTIVES: I. Determine the complete and partial remission rates and remission duration in patients with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78. II. Determine the safety and toxicity of this treatment regimen in this patient population. OUTLINE: 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. Patients are followed every 3 months for 1 year and then every 6 months for 1 year or until relapse. PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | nelarabine | Given IV |
Timeline
- Start date
- 2000-05-01
- Primary completion
- 2006-01-01
- First posted
- 2004-04-19
- Last updated
- 2013-01-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00005080. Inclusion in this directory is not an endorsement.