Trial record 6 of 60 for:    SGN-35

Mocetinostat (MGCD0103) Plus Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborator:
MethylGene Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02429375
First received: April 24, 2015
Last updated: April 28, 2015
Last verified: April 2015
  Purpose

The purpose of this study is to find out how safe and effective treatment with a new combination of drugs, mocetinostat and brentuximab vedotin, is in treating cancer. There will be 2 parts to this trial: a phase I part and a phase II part.

Brentuximab vedotin is approved by the U.S. Food and Drug Administration (FDA) to be given to patients with Hodgkin Lymphoma. Mocetinostat is an experimental drug that has been given to patients with Hodgkin lymphoma in another clinical trial. When given alone, mocetinostat caused lymphoma to shrink in about 1 out of 4 patients with Hodgkin lymphoma. This is the first study that will give mocetinostat and brentuximab vedotin together.


Condition Intervention Phase
Hodgkin Lymphoma
Drug: Mocetinostat Plus Brentuximab Vedotin
Phase 1
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: Phase IB/II Study of Mocetinostat (MGCD0103) Plus Brentuximab Vedotin (SGN-35) in Patients With Relapsed or Refractory Hodgkin Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • maximum tolerated dose (MTD) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    For this objective the standard 3+3 dose-escalation scheme will be used. Patients will be accrued to the study in cohorts of 3 (starting with dose level 1). For any given dose an initial cohort of 3 patients will be treated at that dose. The dose level will be escalated if none of the 3 patients exhibits any DLT


Secondary Outcome Measures:
  • overall response rate (ORR) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    five-point scale for assessing response on interim FDG-PET/CT scans, referred to as the Deauville score was developed by international experts in Nuclear Medicine and Oncology for use in diffuse large B cell lymphoma and HL and validated for use as interim assessment in HL patients.


Estimated Enrollment: 44
Study Start Date: April 2015
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mocetinostat (MGCD0103) Plus Brentuximab Vedotin (SGN-35)
Patients with relapsed or refractory Hodgkin lymphoma will receive brentuximab vedotin combined with mocetinostat. For the phase I portion of the study, patients will be enrolled in a traditional 3 + 3 phase 1 design on sequential dosing cohorts in order to determine the maximum tolerated dose (MTD) of mocetinostat when given with brentuximab vedotin. Once the MTD is determined, (up to) an additional 26 patients will be enrolled on to the phase II portion of the study at the MTD to determine the response rate and toxicity associated with treatment. The phase Ib and II study will include a lead-in with mocetinostat alone for 1 week followed by the combined treatment beginning day 15 following initiation of mocetinostat.
Drug: Mocetinostat Plus Brentuximab Vedotin
All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
Other Names:
  • MGCD0103
  • SGN-35

  Eligibility

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

Inclusion Criteria:

  • Patients must have histologically confirmed CD30 positive relapsed or refractory Hodgkin lymphoma
  • Measurable disease, as defined by the International Harmonization Project.14
  • Patients must have failed autologous stem cell transplant or at least 2 prior cytotoxic regimens for Hodgkin lymphoma. Patients who have failed only 1 prior cytotoxic regimen for Hodgkin lymphoma are permitted to enroll as long as they are not eligible for autologous stem cell transplant.
  • Age ≥18
  • ECOG performance status ≤2 (Karnofsky ≥60%)
  • Patients must have normal organ and marrow function as defined below:

    • absolute neutrophil count ≥1,000/mcL
    • platelets ≥75,000/mcL
    • total bilirubin within normal institutional limits or < 3x the upper limit of normal in patients with Gilbert's disease
    • AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
    • Creatinine ≤1.5 x institutional upper limit of normal OR creatinine clearance ≥40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  • QTc ≤ 500 ms
  • The effects of mocetinostat and brentuximab vedotin on the developing human fetus are potentially harmful. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of mocetinostat and brentuximab vedotin administration.
  • Patients with known HIV infection must have CD4 count greater than 200.

Exclusion Criteria:

  • Presence of a small (or greater size) pericardial effusion; definitions of pericardial effusions by echocardiographic assessment.
  • Patients who have had chemotherapy or radiotherapy within 3 weeks prior to entering the study
  • Patients who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
  • Patients who are receiving any other investigational agents.
  • Patients with known cerebral or meningeal involvement by lymphoma are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to mocetinostat or brentuximab vedotin.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled diabetes, clinically significant pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Women who are pregnant or breastfeeding
  • Previous primary progression or grade 3 toxicity on treatment with brentuximab vedotin
  • Systemic steroids are allowed as long as they are tapered to the equivalent of 20mg prednisone daily or less by the start of cycle 2.
  • Platelet or packed red blood cell transfusion within 14 days of pre-treatment evaluation
  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: NCT02429375

Contacts
Contact: Alison Moskowitz, MD 212-639-4839
Contact: Craig Moskowitz, MD 212-639-2696

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Allison Moskowitz, MD    212-639-4839      
Contact: Craig Moskowitz, MD    212-639-2696      
Principal Investigator: Allison Moskowitz, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
MethylGene Inc.
Investigators
Principal Investigator: Alison Moskowitz, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02429375     History of Changes
Other Study ID Numbers: 14-232
Study First Received: April 24, 2015
Last Updated: April 28, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan Kettering Cancer Center:
Mocetinostat (MGCD0103)
Brentuximab Vedotin (SGN-35)
Relapsed
Refractory

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
N-(2-aminophenyl)-4-((4-pyridin-3-ylpyrimidin-2-ylamino)methyl)benzamide
Enzyme Inhibitors
Histone Deacetylase Inhibitors
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 30, 2015