Know Cancer

or
forgot password

A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Patients With Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma


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

Thank you

Trial Information

A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Patients With Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

Inclusion Criteria


INCLUSION:

- Bidimensionally measurable current/refractory aggressive NHL (Diffuse lg cell,
diffuse mixed cell, follicular lg non-cleaved, immunoblastic, Ki-1+ALCL, peripheral
T-cell lymphoma, mantle cell lymphoma & transformed lymphoma.)

- No more than 3 prior treatment regimens. No anti-lymphoma therapy within the past 3
weeks.

- Not be eligible for treatment of a higher priority.

- Performance status <2 Zubrod, > 60 Karnofsky.

- Good marrow reserve: ANC>1.5 x 10(9)/L, platelets > 100 x 10(9)/L.

- Bilirubin <1.5mg/dL, SGOT, SGPT < 2 x normal values.

- Serum creatinine < 1.8 mg/dL.

- Age > 18 yrs.

- Signed informed consent.

- Life expectancy of > 12 weeks.

- No prior Taxane (paclitaxel or docetaxel), topotecan, or CPT-11.

- No prior stem cell or bone marrow transplantation.

- No prior second malignancies except for basal cell carcinoma of the skin.

EXCLUSION:

- Active or prior history of CNS lymphoma.

- Serious intercurrent medical illnesses requiring hospitalization.

- History of primary/secondary immunodeficiency (other than related to the malignant
lymphoma because treatment is dependent on a functional immune system) or patients
taking immunosuppressive drugs (systemic corticosteroids).

- Prior exposure to Filgrastim-SD/01.

- Women who are pregnant or lactating.

- Participation in another clinical trial.

- Positive HIV antibody.

- History of prior sensitivity to E. coli derived products (such as
filgrastim/neupogen).

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Anas Younes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

DM01-008

NCT ID:

NCT00038545

Start Date:

May 2001

Completion Date:

April 2004

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • LYMPHOMA
  • NON-HODGKINS
  • AGGRESSIVE
  • RELAPSED AND REFRACTORY
  • Aggression
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030