Clinical trial NCT00461084: Biaxin Based Antibiotic Therapy in Previously Untreated, Advanced Stage Indolent Lymphoma
Official title: Biaxin(Clarithromycin)Based Antibiotic Therapy In Previously Untreated, Advanced Stage Indolent Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Keywords: Lymphoma
Advanced Stage
Untreated
Advanced Stage Lymphoma
Untreated Lymphoma
07-038
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-04-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously Untreated follicular lymphoma or non-follicular lymphoma will be recrited at MSKCC

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 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.

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 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

Primary outcomes:
measure: 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,).
timeFrame: conclusion of study
Secondary outcomes:
measure: The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin (clarithromycin) response and progression
timeFrame: conclusion of study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Carol Portlock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Portlock CS, Hamlin PA, Gerecitano JF, Noy A, Palomba ML, Walkley J, Corcoran S, Migliacci J, Schoder H, Papanicolaou G, Markowitz AJ. A Positive Prospective Trial of Antibiotic Therapy in Advanced Stage, Non-Bulky Indolent Lymphoma. Tumor Microenviron Ther. 2015 Feb;2(1):14-18. doi: 10.1515/tumor-2015-0001. Epub 2015 Feb 18.