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Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma


Phase 2
16 Years
N/A
Not Enrolling
Both
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome

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Trial Information

Phase II Study of 506U78 (NSC #686673) in Patients With Previously Treated Cutaneous T-Cell Lymphoma


PRIMARY OBJECTIVES:

I. Determine the response rate, failure-free survival, and progression-free survival of
patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78.

II. Determine the toxicity of this drug in these patients. III. 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.


Inclusion Criteria:



- Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma

- Large cell transformation of cutaneous T-cell lymphoma allowed

- No active CNS disease

- Performance status - Zubrod 0-2

- Absolute neutrophil count at least 1,000/mm^3*

- Platelet count at least 100,000/mm^3*

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGPT no greater than 2.5 times ULN

- Creatinine clearance greater than 50 mL/min

- No history of symptomatic cardiac dysfunction

- No history of pericardial effusion

- 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

- 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

- 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

- At least 3 weeks since prior anticancer endocrine therapy

- No concurrent topical or systemic steroids

- 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

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (RR) defined as CR + PR rates

Outcome Time Frame:

Up to 4 years

Safety Issue:

No

Principal Investigator

Andre Goy

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02344

NCT ID:

NCT00005982

Start Date:

April 2000

Completion Date:

Related Keywords:

  • Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
  • Recurrent Mycosis Fungoides/Sezary Syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

M D Anderson Cancer CenterHouston, Texas  77030