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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00461084
First received: April 13, 2007
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Lymphoma
 Drug: BIAXIN (CLARITHROMYCIN)
Drug: Biaxin (clarithromycin)
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biaxin(Clarithromycin)Based Antibiotic Therapy In Previously Untreated, Advanced Stage Indolent Lymphoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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,). [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin (clarithromycin) response and progression [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

tissue and whole blood


Estimated Enrollment: 74
Study Start Date: April 2007
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
lymphoma follicular
 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.
2
lymphoma non-follicular
 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.

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 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Previously Untreated follicular lymphoma or non-follicular lymphoma will be recrited at MSKCC

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461084

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Carol Portlock, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Memorial Sloan-Kettering Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00461084     History of Changes
Other Study ID Numbers: 07-038
Study First Received: April 13, 2007
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Lymphoma
Advanced Stage
Untreated
 Advanced Stage Lymphoma
Untreated Lymphoma
07-038

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anti-Bacterial Agents
 Clarithromycin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013