Biaxin Based Antibiotic Therapy in Previously Untreated, Advanced Stage Indolent Lymphoma

Lymphoma Clinical Trial

Official title:

Biaxin(Clarithromycin)Based Antibiotic Therapy In Previously Untreated, Advanced Stage Indolent Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461084
• Other study ID #: 07-038
• Status: Completed
• Phase: Phase 2
• First received: April 13, 2007
• Last updated: September 17, 2014
• Start date: April 2007
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 would also like to see how Biaxin (clarithromycin) works on lymphoma and blood cells.There is some evidence that this medication may change the behavior of lymphocytes, in addition to its known anti-infection activity.

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 (utilizing GELF criteria,). This is the primary objective Response rate (CR + PR) stratified for Follicular/Non-Follicular disease.

The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin (clarithromycin) response and progression:

Response rate (CR + PR) according to H. pylori positive or negative (RR with a confidence interval will be estimated for each subset). Immunohistochemistry in all diagnostic biopsy specimens: Lymphocyte- Activated Macrophage (CD68) and other selected markers to clarify tumor infiltrating cells. Peripheral blood mononuclear cell (PBMCs) studies to evaluate possible HDAC (histone deacetylase) inhibition with biaxin (clarithromycin) therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• BIAXIN (CLARITHROMYCIN)
Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
• Biaxin (clarithromycin)
Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 (utilizing GELF criteria,).		conclusion of study	No
Secondary	The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin (clarithromycin) response and progression		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center