Status:
COMPLETED
Biaxin Based Antibiotic Therapy in Previously Untreated, Advanced Stage Indolent Lymphoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to see if a treatment with Biaxin (clarithromycin) which is an antibiotic given by mouth for 3 months can delay the growth of your lymphoma or shrink the lymphoma. We woul...
Detailed Description
The primary objective of this study is to evaluate a biaxin (clarithromycin)-based antibiotic therapy in previously untreated patients with indolent lymphoma who do not require active lymphoma therapy...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of follicular lymphoma: grades I, II, or IIIA, or non-follicular lymphoma: lymphoplasmacytoid lymphoma, small lymphocytic lymphoma, marginal B-cell lymphoma, or MALT lymphoma (as defined in the WHO classification1) as reviewed by a hematopathologist at Memorial Hospital.
- Staging fulfills criteria for no initial treatment according to GELF criteria for advanced stage disease. None of the following should be present:
- A nodal or extranodal mass with a diameter of \>7 cm,
- Involvement of at least three nodal sites \[each with a diameter of \>3 cm\],
- Systemic symptoms,
- Symptomatic splenomegaly,
- Ureteral compression.
- No prior treatment for lymphoma is permitted.
- Measurable disease is required.
- Karnofsky performance status \> 70%
- The patient may not have a previous history of radiation therapy.
- Patient or guardian must be able to sign voluntary written consent.
- Male or female patients 18 years of age or greater.
Exclusion
- Allergy to biaxin (clarithromycin), erythromycin, or other macrolide antibiotic. Patients requiring use of ergot derivatives, pimozide, cisapride, or astemizole; combination with ranitidine bismuth citrate should not be used in patients with history of acute porphyria or CrCl \<25 mL/minute.
- Prior treatment with Biaxin (clarithromycin) during the prior 6 months.
- Histologic diagnosis of follicular grade 3B or aggressive non-Hodgkin's lymphoma.
- Histologic evidence of transformation from low grade/indolent NHL to aggressive NHL.
- Prior treatment for non-Hodgkin's lymphoma.
- Regional lymphoma (peripheral stages I and II) eligible for involved field irradiation.
- GELF criteria21 for institution of systemic chemotherapy, which includes:
- A nodal or extranodal mass with a diameter of \>7 cm,
- Involvement of at least three nodal sites \[each with a diameter of \>3 cm\],
- Systemic symptoms,
- Symptomatic splenomegaly,
- Ureteral compression.
- Patients with a known history of HIV, Hepatitis B or C seropositivity.
- Patients who require therapy with systemic corticosteroids.
- Prior history of malignancy within the past five years or a concurrent malignancy, with the exceptions of cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix.
- Pregnant or lactating women, since imaging cannot be done in this setting.18
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00461084
Start Date
April 1 2007
End Date
September 1 2014
Last Update
September 18 2014
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065