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A Multicenter Open-Label Non-Randomized Phase II Study of Elsamitrucin (SPP 28090) in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Multicenter Open-Label Non-Randomized Phase II Study of Elsamitrucin (SPP 28090) in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma


Inclusion Criteria:



- Histologically confirmed NHL both B and T-cell that is refractory to or has relapsed
after standard therapy or for which there is no known effective treatment.

- CT or MRI scans confirming measurable tumor size (lymph node must be >1.0 cm in its
longest transverse diameter). Measurement by PE is acceptable, in the case of
palpable and reproducibly measurable tumors. Patients with CLL/smal lymphocytic
lymphoma are eligible without bidimensional measurable disease.

- ECOG Performance Status 0-2

- Age greater or equal to 18 years of old

- AGC greater or equal to 1.0; platelets greater or equal to 75,000;Ggb greater or
equal to 9.0. (Lower values may be accepted for cytopenias due to bone marrow
involvement by lymphoma, after discussion with sponsor)

- Bilirubin less or equal to 2.0; SGOT and SGPT less of equal to 3 times upper limit of
normal

- Creatinine <1.5; BUN <25

- Expected survival >6 months

Exclusion Criteria:

- Prior therapy with Elsamitrucin

- Any therapy for lymphoma, including chemotherapy, antibody therapy, RT, or any
investigational therapy within 28 days prior to study drug administration

- Steroid therapy within the last 4 weeks prior to study drug administration

- Evidence of clinically significant uncontrolled condition/s and/or is considered by
investigator to be unable to tolerate the required therapy or procedures

- Known AIDS syndrome or HIV-associated complex (severely depressed immune system)

- Prior or other current malignancy within 5 years, except for adequately treated
cone-biopsied in-situ cervical cancer or resected basal cell or squamous cell skin
cancer

- Any current medical or psychiatric disease that would prevent informed consent and
expected cooperation of the patient for therapy and follow-up

- Pregnant or lactating women.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Ann Mohrbacher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Southern California

Authority:

United States: Institutional Review Board

Study ID:

13NHL-04-1

NCT ID:

NCT00184080

Start Date:

May 2004

Completion Date:

April 2006

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800