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

NCT01555853 | Terminated Phase 1

• 1 other identifier: 201204071
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease

Outcome Measures

Primary Outcomes (3)

• Phase I: Maximum tolerated dose (MTD) of Abraxane in patients with recurrent or refractory lymphoma

  Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4.

  28 days (completion of cycle 1) for all patients in Phase I portion

• Phase I: Dose-limiting toxicities (DLTs) of Abraxane in patients with recurrent or refractory lymphoma

  Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4

  28 days (completion of cycle 1)

• Phase II: Overall response rate (CR + PR)

  24 weeks (end of study)

Secondary Outcomes (5)

• Phase I: Toxicity associated with Abraxane

  28 weeks (30 days after completion of study treatment)

• Phase II: Time to progression.

  24 weeks (end of study)

• Phase II: Duration of remission

  24 weeks (end of study)

• Phase II: Overall survival.

  3 years

• Phase II: Clinical benefit (CR + PR + SD)

  24 weeks (end of study)

Study Arms (4)

Phase I-Dose Level 0

EXPERIMENTAL

Abraxane 100 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles.

Drug: Abraxane

Phase I-Dose Level 1

EXPERIMENTAL

Abraxane 125 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles.

Drug: Abraxane

Phase I-Dose Level 2

EXPERIMENTAL

Abraxane 150 mg/m2 IV on Days 1, 8, and 15 of each 28 day cycle for a maximum of 6 cycles.

Drug: Abraxane

Phase II

EXPERIMENTAL

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

Interventions

Abraxane DRUG

Also known as: ABI-007

Phase I-Dose Level 0; Phase I-Dose Level 1; Phase I-Dose Level 2; Phase II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (2)

St. Louis University School of Medicine

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Hodgkin Disease

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Nancy Bartlett, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 16, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

US (2)