Know Cancer

forgot password

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)

Phase 2
69 Years
Not Enrolling
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

Thank you

Trial Information

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)


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.


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

PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years.

Inclusion Criteria:

- 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,

- 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

- 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

- No history of a seizure disorder or grade 3 neurologic toxicity during prior
treatment of lymphoma. Baseline neurologic status of all eligible patients is to be
carefully recorded (particularly in elderly patients and those with conditions
potentially predisposed to neurotoxicity, such as diabetes mellitus and prior
exposure to neurotoxic agents); patients with prior neurologic dysfunction or
toxicity from any cause must have recovered to grade 1 neurologic

- Performance status 0-2

- No known HIV disease; patients with a history of intravenous drug abuse or any other
behavior associated with an increased risk of HIV infection should be tested for
exposure to the HIV virus; patients who test positive or who are known to be infected
are not eligible; an HIV test is not required for entry on protocol, but is required
if the patient is perceived to be at risk

- Calculated Creatinine Clearance >= 50 ml/min

- Unless attributable to lymphoma

- To be calculated by method of Cockcroft-Gault

- Bilirubin >= 1.5 x upper limit of normal

- Patients with hepatic dysfunction should enroll on CALGB 69803

Type of Study:


Study Design:

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

Outcome Measure:

Remission rate (complete and partial remission)

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

Myron Czuczman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

May 2000

Completion Date:

Related Keywords:

  • 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
  • Immunoblastic Lymphadenopathy
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Mycoses
  • Mycosis Fungoides
  • Sezary Syndrome
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic



Cancer and Leukemia Group B Chicago, Illinois  60606