Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar

NCT00475332 | Terminated Phase 2 Results

• 1 other identifier: GSK Protocol #109407
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the feasibility of treating relapsed follicular lymphoma with a combination of Bexxar and External Beam Radiotherapy (EBRT). Patients will receive EBRT (20 Gy in 10 fractions) followed by Bexxar.

Conditions

Non-Hodgkin's Lymphoma; Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint of the Study Will be to Determine the Feasibility of Combining External Beam Radiotherapy (EBRT) and Bexxar by Assessing the Toxicities Associated With the Treatment.

  13 patients will be enrolled initially and followed for 3 months. If less than 10 of these patients reach a grade III or IV toxicity, then 12 more patients will be enrolled and the study will be deemed feasible. If 11 or more of the first group experience grade III/IV toxicity, the trial will stop early.

  2 yr 3 mos

Secondary Outcomes (1)

• The Secondary Endpoint Will be to Assess Response Rates and Patterns of Failure in Patients Treated With Bexxar and External Beam Radiotherapy (EBRT).

  2 yr 3 mos

Interventions

Iodine I -01 Tositumomab (Bexxar) DRUG

Patients will be treated in two dosing phases, each phase includes two infusions. The first phase, termed "dosimetric dose," involves an intravenous administration of 450 mg unlabeled tositumomab followed by an intravenous administration of 5 mCi (0.18 GBq) of I-131 tositumomab for the purpose of determining the rate of whole body clearance of radioactivity (residence time) so that the administered activity (mCi or GBq) to deliver a 75 cGy (or 65 cGy for patients with baseline platelet count from 100,000 to 149,999/mm\^3) total body radiation dose can be calculated.

External Beam Radiation Therapy PROCEDURE

All patients are to receive 20 Gy in 10 fractions of 200 cGy to the PTV

Eligibility Criteria

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

You may qualify if:

• Relapsed Stage I-IV (no evidence of bone marrow involvement) Follicular Non- Hodgkin's Lymphoma (NHF). Patients must have received at least 1 prior therapeutic regimen of chemotherapy or Rituximab and demonstrated progression as demonstrated by biopsy.
• One or more of the relapsed sites must be 5 cm or greater in dimension as assessed on two dimensional imaging from CT or MRI scan.
• Biopsy at time of relapse confirming continued presence of CD 20 positive follicular lymphoma.
• No anti-cancer therapy for 3 weeks (six weeks if Rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, chemotherapy, or immunotherapy.
• An IRB-approved signed informed consent.
• Expected survival rate greater than 3 months.
• Prestudy performance status of 0 or 1 according to the World Health Organization (WHO) criteria
• Acceptable hematologic status within two weeks prior to patient registration, including:
• Absolute neutrophil count (ANC) (\[segmented neutrophils + bands\] x total white blood cells) greater than 1,500/mm\^3
• Platelet counts greater than 100,000/mm\^3
• Female patients who are not pregnant or lactating.
• Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, however, abstinence is not an acceptable method).
• Patients previously on Phase II drugs if no long-term toxicity is expected, and the patient has been off the drug for eight or more weeks with no significant post-treatment toxicities observed.

You may not qualify if:

• Patients with impaired bone marrow reserve, as indicated by one or more of the following:
• Prior myeloablative therapies with bone marrow transplantation (either autologous or allogeneic) or peripheral blood stem cell (PBSC) rescue.
• Platelet count \> 100,000 cells/mm\^3
• Hypocellular bone marrow
• Marked reduction in bone marrow precursors of one or more cell lines (granulocytic,megakaryocytic, erythroid).
• History of failed stem cell collection
• Presence of bone marrow involvement with follicular lymphoma (FL) \> 25% based on bone marrow biopsy done within 2 months of enrollment.
• Evidence of transformation from original FL to a more aggressive NHL histology.
• Prior radioimmunotherapy.
• All relapsed sites are \< 5 cm in dimension as assessed on two dimensional imaging from CT or MRI scan.
• Presence of CNS (central nervous system) involvement.
• Presence of primary Non-Hodgkin Lymphoma (NHL) of bone.
• Patients with HIV or AIDS-related lymphoma.
• Patients with abnormal renal function: serum creatinine \> 2.0 mg/dL.
• Patients who have received prior external beam radiation therapy within three months of registration.

Sponsors & Collaborators

• University of Florida: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (6)

• Wiseman GA, White CA, Sparks RB, Erwin WD, Podoloff DA, Lamonica D, Bartlett NL, Parker JA, Dunn WL, Spies SM, Belanger R, Witzig TE, Leigh BR. Biodistribution and dosimetry results from a phase III prospectively randomized controlled trial of Zevalin radioimmunotherapy for low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma. Crit Rev Oncol Hematol. 2001 Jul-Aug;39(1-2):181-94. doi: 10.1016/s1040-8428(01)00107-x.

  PMID: 11418315 BACKGROUND

• Koral KF, Dewaraja Y, Li J, Lin Q, Regan DD, Zasadny KR, Rommelfanger SG, Francis IR, Kaminski MS, Wahl RL. Update on hybrid conjugate-view SPECT tumor dosimetry and response in 131I-tositumomab therapy of previously untreated lymphoma patients. J Nucl Med. 2003 Mar;44(3):457-64.

  PMID: 12621015 BACKGROUND

• Koral KF, Dewaraja Y, Li J, Barrett CL, Regan DD, Zasadny KR, Rommelfanger SG, Francis IR, Kaminski MS, Wahl RL. Initial results for Hybrid SPECT--conjugate-view tumor dosimetry in 131I-anti-B1 antibody therapy of previously untreated patients with lymphoma. J Nucl Med. 2000 Sep;41(9):1579-86.

  PMID: 10994741 BACKGROUND

• Gokhale AS, Mayadev J, Pohlman B, Macklis RM. Gamma camera scans and pretreatment tumor volumes as predictors of response and progression after Y-90 anti-CD20 radioimmunotherapy. Int J Radiat Oncol Biol Phys. 2005 Sep 1;63(1):194-201. doi: 10.1016/j.ijrobp.2005.01.017.

  PMID: 16111589 BACKGROUND

• Kaminski MS, Zelenetz AD, Press OW, Saleh M, Leonard J, Fehrenbacher L, Lister TA, Stagg RJ, Tidmarsh GF, Kroll S, Wahl RL, Knox SJ, Vose JM. Pivotal study of iodine I 131 tositumomab for chemotherapy-refractory low-grade or transformed low-grade B-cell non-Hodgkin's lymphomas. J Clin Oncol. 2001 Oct 1;19(19):3918-28. doi: 10.1200/JCO.2001.19.19.3918.

  PMID: 11579112 BACKGROUND

• Kaminski MS, Tuck M, Estes J, Kolstad A, Ross CW, Zasadny K, Regan D, Kison P, Fisher S, Kroll S, Wahl RL. 131I-tositumomab therapy as initial treatment for follicular lymphoma. N Engl J Med. 2005 Feb 3;352(5):441-9. doi: 10.1056/NEJMoa041511.

  PMID: 15689582 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Follicular

Interventions

tositumomab I-131

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The PI left our institution and the study was closed. There were only 2 patients enrolled on the study so no conclusions can be drawn regarding the objectives of the study.

Results Point of Contact

• Title: Bridget Fitzgerald, Clinical trials coordinator
• Organization: University of Florida

fitzgb@shands.ufl.edu

(352) 265-0680

Study Officials

• Robert J Amdur, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 21, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 15, 2012
• Results First Posted: February 15, 2012

Record last verified: 2012-01

Locations

US (1)