Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00705250
First received: June 24, 2008
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

The standard treatment for patients with HL that has not responded to treatment or has come back after treatment is stem cell transplant. When patients are not eligible for transplant or when HL comes back after transplant, there are no standard treatment options. These patients can receive chemotherapy or participate in clinical trials. Bendamustine HCl is a chemotherapy agent that is effective in treating patients with various diseases, including non-Hodgkin's lymphoma, multiple myeloma, and breast cancer. It was recently approved for the treatment of chronic lymphocytic leukemia. In addition, small studies from Eastern Europe have shown that bendamustine HCl is likely effective for treating HL. This study will find out the effect of bendamustine HCl for transplant-ineligible patients with HL that has not responded to or has come back after treatment.


Condition Intervention Phase
Hodgkin's Disease
Lymphoma
Drug: bendamustine hcl
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Bendamustine HCL in Relapsed and Primary Refractory Hodgkin Lymphoma.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Determine the overall response rate (RR) to bendamustine HCL in patients with relapsed and primary refractory HL. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine rate of complete remission (CR) and partial remission (PR). [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • Evaluate toxicity according to CTCAE v3.0 criteria. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]
  • Determine progression free survival (PFS) and overall survival (OS) following treatment with bendamustine HCL in patients with relapsed and primary refractory HL. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • Correlate response to bendamustine HCl with p53 mutation status [ Time Frame: Conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: June 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
bendamustine hcl 120mg/m2
Drug: bendamustine hcl
Patients will receive bendamustine 120mg/m2, administered as a 30-minute infusion, for two consecutive days. Cycles will be repeated every four weeks and a total of 6 cycles will be planned. Patients will receive pegfilgrastim with each cycle. Treatment will be delayed until the absolute neutrophil count is > 1000/ul and the platelet count is > 75,000/ul.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic diagnosis of Classical Hodgkin lymphoma, confirmed by the department of hematopathology at MSKCC. Patients who have relapsed after an autologous stem cell transplant must have a biopsy after transplant to confirm relapsed Hodgkin's disease. Patients who have relapsed after an allogeneic transplant must also have a biopsy posttransplant.
  • Age > or = to 18
  • All patients must have PET avid measurable disease.
  • Last chemotherapy > or = to 4 weeks from the start of Bendamustine HCl
  • Receiving no other treatment for HL
  • Patients must have normal baseline cardiac function based upon echocardiogram or gated blood pool scan (MUGA) with an ejection fraction > or = to 50%
  • Patients must have a serum creatinine of < or = to 1.5 mg/dl; if creatinine >1.5 mg/dl creatinine clearance must be >60 ml/minute.
  • Patients must have ANC>1000/mcl and Platelets>100,000/mcl.
  • Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's).
  • Patients must be Hepatitis B surface antigen and Hepatitis B core antibody negative and Hepatitis C negative.
  • Patients must have failed an autologous stem cell transplant or be ineligible for an autologous stem cell transplant due to chemo-refractory disease(as defined as <50% response to standard salvage chemotherapy).
  • Women who are pre-menopausal must have a negative pregnancy test
  • Subjects must agree to use appropriate contraception until 4 weeks after the completion of chemotherapy.
  • Patients must be HIV negative.
  • If patients have a history of malignancy other than cutaneous basal cell or squamous cell carcinoma, they must be disease-free for ≥ 5 years at the time of enrollment.
  • Patients or their guardians must be capable of providing informed consent.

Exclusion Criteria:

  • Patients with either parenchymal brain or lepto-meningeal involvement.
  • 7 or more consecutive days of prednisone therapy prior to therapy.
  • Known pregnancy or breast-feeding.
  • Medical illness unrelated to HL, which in the opinion of the attending physician and principal investigator will preclude administration of chemotherapy safely. This includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis
  • History of any malignancy for which the disease-free interval is <5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix.
  • Relapse <6 months post allogeneic stem cell transplant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705250

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Cephalon
Investigators
Principal Investigator: Craig Moskowitz, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided by Memorial Sloan-Kettering Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00705250     History of Changes
Other Study ID Numbers: 08-041
Study First Received: June 24, 2008
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Bendamustine HCL

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bendamustine
Nitrogen Mustard Compounds
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014