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Phase I/II Study of Abraxane in Recurrent and Refractory Lymphoma

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ClinicalTrials.gov Identifier: NCT01555853
Recruitment Status : Terminated (completed accrual to phase I but drug did not show activity, so halted before initiation of phase II)
First Posted : March 16, 2012
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Hodgkin Disease Drug: Abraxane Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Institutional Study of Abraxane in Recurrent and Refractory Lymphoma
Study Start Date : July 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.

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

  3. Phase II: Overall response rate (CR + PR) [ Time Frame: 24 weeks (end of study) ]

Secondary Outcome Measures :
  1. Phase I: Toxicity associated with Abraxane [ Time Frame: 28 weeks (30 days after completion of study treatment) ]
  2. Phase II: Time to progression. [ Time Frame: 24 weeks (end of study) ]
    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.

  3. Phase II: Duration of remission [ Time Frame: 24 weeks (end of study) ]
  4. Phase II: Overall survival. [ Time Frame: 3 years ]
  5. Phase II: Clinical benefit (CR + PR + SD) [ Time Frame: 24 weeks (end of study) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 chemotherapy, immunotherapy, radiotherapy, and/or investigational agents while on study.
  • 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 investigational agents and/or radiotherapy < 3 weeks prior to starting study drug.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01555853


Locations
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United States, Missouri
St. Louis University School of Medicine
St. Louis, Missouri, United States, 63110
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Nancy Bartlett, M.D. Washington University School of Medicine
More Information
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Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01555853     History of Changes
Other Study ID Numbers: 201204071
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Albumin-Bound Paclitaxel
Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action