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

Overview[ - collapse ][ - ]

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.
ConditionLymphoma, Non-Hodgkin
Hodgkin Disease
InterventionDrug: Abraxane
PhasePhase 1/Phase 2
SponsorWashington University School of Medicine
Responsible PartyWashington University School of Medicine
ClinicalTrials.gov IdentifierNCT01555853
First ReceivedMarch 13, 2012
Last UpdatedJanuary 13, 2014
Last verifiedJanuary 2014

Tracking Information[ + expand ][ + ]

First Received DateMarch 13, 2012
Last Updated DateJanuary 13, 2014
Start DateJuly 2012
Estimated Primary Completion DateJune 2015
Current 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief TitlePhase I/II Study of Abraxane in Recurrent and Refractory Lymphoma
Official TitleA Phase I/II Institutional Study of Abraxane in Recurrent and Refractory Lymphoma
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 1/Phase 2
Study DesignAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Lymphoma, Non-Hodgkin
  • Hodgkin Disease
InterventionDrug: Abraxane
Other Names:
ABI-007
Study Arm (s)
  • 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.
  • 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.
  • 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.
  • 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.

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment54
Estimated Completion DateJune 2015
Estimated Primary Completion DateJune 2015
Eligibility 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsContact: Nina Wagner-Johnston, M.D.
314-362-5654
nwagner@dom.wustl.edu
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01555853
Other Study ID Numbers201204071
Has Data Monitoring CommitteeNo
Information Provided ByWashington University School of Medicine
Study SponsorWashington University School of Medicine
CollaboratorsNot Provided
Investigators Study Director: Nina Wagner-Johnston, M.D. Washington University School of Medicine
Verification DateJanuary 2014

Locations[ + expand ][ + ]

Washington University School of Medicine
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.
Recruiting
St. Louis University School of Medicine
St. Louis, Missouri, United States, 63110
Contact: Sagun Goyal, M.D. | 314-577-8854 | sgoyal@slu.edu
Principal Investigator: Sagun Goyal, M.D.
Not yet recruiting