Trial record 1 of 1 for:    NCT01555853
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Phase I/II Study of Abraxane in Recurrent and Refractory Lymphoma

This study is currently recruiting participants.
Verified January 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01555853
First received: March 13, 2012
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

This phase I/II trial studies the side effects, maximum tolerated dose, and effectiveness of paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) in treating patients with recurrent or refractory Hodgkin or B-cell non-Hodgkin lymphoma. More effective and well tolerated therapies are needed to treat patients with relapsed and refractory lymphomas. Nab-paclitaxel combines a chemotherapeutic agent with a protein which may increase the anticancer drug concentration in the tumor while reducing toxic effects in normal tissue and may be an effective treatment for lymphoma.


Condition Intervention Phase
Lymphoma, Non-Hodgkin
Hodgkin Disease
Drug: Abraxane
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Institutional Study of Abraxane in Recurrent and Refractory Lymphoma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Phase I: Maximum tolerated dose (MTD) of Abraxane in patients with recurrent or refractory lymphoma [ Time Frame: 28 days (completion of cycle 1) for all patients in Phase I portion ] [ Designated as safety issue: Yes ]
    Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.

  • Phase I: Dose-limiting toxicities (DLTs) of Abraxane in patients with recurrent or refractory lymphoma [ Time Frame: 28 days (completion of cycle 1) ] [ Designated as safety issue: Yes ]
    Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4

  • Phase II: Overall response rate (CR + PR) [ Time Frame: 24 weeks (end of study) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase I: Toxicity associated with Abraxane [ Time Frame: 28 weeks (30 days after completion of study treatment) ] [ Designated as safety issue: Yes ]
  • Phase II: Time to progression. [ Time Frame: 24 weeks (end of study) ] [ Designated as safety issue: No ]
    Response and progression will be recorded with each imaging evaluation according to the 2007 revised response criteria for malignant lymphoma by Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-86.

  • Phase II: Duration of remission [ Time Frame: 24 weeks (end of study) ] [ Designated as safety issue: No ]
  • Phase II: Overall survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Phase II: Clinical benefit (CR + PR + SD) [ Time Frame: 24 weeks (end of study) ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: July 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase I-Dose Level 0
Abraxane 100 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles.
Drug: Abraxane
Other Name: ABI-007
Experimental: Phase I-Dose Level 1
Abraxane 125 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles.
Drug: Abraxane
Other Name: ABI-007
Experimental: Phase I-Dose Level 2
Abraxane 150 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles.
Drug: Abraxane
Other Name: ABI-007
Experimental: Phase II
Abraxane (dose to be determined in Phase I) IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles.
Drug: Abraxane
Other Name: ABI-007

  Eligibility

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

Inclusion Criteria:

  • Patient must have histologically confirmed B-cell non-Hodgkin lymphoma or classical Hodgkin lymphoma:
  • Diffuse large B-cell lymphoma (including transformed large cell lymphoma and primary mediastinal B cell lymphoma)
  • Mantle cell lymphoma
  • Burkitt's lymphoma
  • Follicular lymphoma
  • Small lymphocytic lymphoma
  • Marginal zone lymphoma
  • Lymphoplasmacytic lymphoma
  • Classical Hodgkin lymphoma (including nodular sclerosis, mixed cellularity, lymphocyte rich, and lymphocyte deplete)
  • Patient must have measurable disease, defined as the presence of ≥ 1 lymph node or tumor mass measuring ≥ 1 cm in a single dimension as assessed by CT or MRI.
  • Patient must have had prior treatment with ≥ 2 chemotherapy or chemo-immunotherapy regimens. Prior autologous stem cell transplant is allowed, and prior allogeneic stem cell transplant is allowed as long as the patient has recovered from acute toxicities and is off immunosuppression without evidence of graft versus host disease (GVHD).
  • Patient must be ≥ 18 years of age.
  • Patient must have an ECOG performance status ≤ 2.
  • Patient must have adequate bone marrow reserve at the time of therapy initiation, defined as ANC ≥ 1.0 x 109/L and platelets ≥ 50 x 109/L.
  • Patient must have adequate hepatic function, defined as total bilirubin ≤ 1.5 x ULN and AST/ALT ≤ 3 x ULN.
  • Patient must have adequate renal function, defined as serum creatinine ≤ 2.0 x ULN.
  • Patient must have recovered from any acute toxicities associated with prior therapy to ≤ grade 1.
  • Women of childbearing 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 participating in this study, she must inform her treating physician immediately.
  • Patient (or legally authorized representative, if applicable) must be able to understand and willing to sign an IRB approved written informed consent document.
  • Both men and women and members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

  • Patient must not have nodular lymphocyte predominant Hodgkin lymphoma subtype.
  • Patient must not have a history of a non-lymphoma malignancy except for the following: adequately treated localized basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder cancer, localized prostate cancer, any adequately treated stage I or stage II cancer currently in complete remission, or any other cancer in complete remission for at least 5 years.
  • Patient must not be receiving any other investigational agents, and must not have taken any other investigational agents within ≤ 3 weeks of study entry.
  • Patients with Hodgkin's lymphoma must not otherwise be eligible for treatment with brentuximab vedotin.
  • Patient must not have central nervous system or leptomeningeal lymphoma.
  • Patient must not have with history of allergic reactions attributed to compounds of similar chemical or biologic composition to Abraxane.
  • Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patient must not be pregnant and/or breastfeeding.
  • Patient must not be known to be HIV-positive.
  • Patient must not have any pre-existing peripheral neuropathy > grade 1.
  • Patient must not have received any chemotherapy, immunotherapy, and/or radiotherapy ≤ 3 weeks prior to starting study drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555853

Contacts
Contact: Nina Wagner-Johnston, M.D. 314-362-5654 nwagner@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Nina Wagner-Johnston, M.D.    314-362-5654    nwagner@dom.wustl.edu   
Principal Investigator: Nina Wagner-Johnston, M.D.         
Sub-Investigator: Nancy Bartlett, M.D.         
Sub-Investigator: Kenneth Carson, M.D.         
Sub-Investigator: Amanda Cashen, M.D.         
Sub-Investigator: Todd Fehniger, M.D., Ph.D.         
St. Louis University School of Medicine Not yet recruiting
St. Louis, Missouri, United States, 63110
Contact: Sagun Goyal, M.D.    314-577-8854    sgoyal@slu.edu   
Principal Investigator: Sagun Goyal, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Study Director: Nina Wagner-Johnston, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01555853     History of Changes
Other Study ID Numbers: 201204071
Study First Received: March 13, 2012
Last Updated: January 13, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014