Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkin's Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to determine the safety and effectiveness of TNX-650 for Injection when administered to patients with refractory Hodgkin's lymphoma.

Detailed Description

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Hodgkin's lymphoma (HL) is a lymphoid malignancy that accounts for approximately 7,000 to 8,000 new cancer cases per year in the United Sates. It occurs with a bimodal age-incidence distribution peaking in the 15- to 30-year old and 50- to 60-year old age groups. The pathological hallmark of the disease is the presence of malignant Reed Sternberg (RS) cells. Reed-Sternberg cells are interspersed among a heterogeneous population of non-malignant reactive cells, including T cells, eosinophils, neutrophils, B lymphocytes, plasma cells, histiocytes, fibroblasts, and stromal cells.

While more than 80% of patients will respond to initial radiotherapy or combination chemoradiotherapy, some patients will experience early relapse after initial therapy or be refractory to first-line therapy. These patients may be treated with second-line therapy, which may include autologous bone marrow transplantation (BMT). Patients with HL who relapse after first- and second-line therapy, or who are refractory to therapy, with or without autologous BMT, have a poor prognosis. The long-term event-free survival rate in this patient group is less than 10%; median survival is 16 months. At present, these patients have no treatment options other than investigational therapies.

Conditions

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Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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TNX-650

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histological diagnosis of relapsed or refractory classical HL
* Age \>18 years
* Received and failed potentially curative chemotherapeutic regimens (e.g., ABVD, Stanford V, or BEACOPP)
* Relapsed following autologous bone marrow transplantation (BMT), or are ineligible, or refused BMT
* Completed radiotherapy, chemotherapy, and/or treatment with other investigational agents at least 3 weeks prior to study entry
* Completed autologous BMT (if received) at least 3 months prior to study entry; completed allogeneic BMT (if received); at least 6 months prior to study entry
* Eastern Cooperative Oncology Group (ECOG) status of \<2
* Life expectancy of \>3 months
* Laboratory data:

* Platelet count \>50,000/mm3
* Hemoglobin \>9.0 g/dL (may be maintained by transfusion)
* Absolute neutrophil count \>1000/mm3
* ALT/AST \<2.5 times the upper limit of normal (ULN)
* Total bilirubin \<1.5 times ULN
* Creatinine \<1.5 mg/dL
* Female subjects of childbearing potential must have a negative serum pregnancy test at screening; subjects must agree to use a medically appropriate form of birth control from screening until 6 months after the last dose of study medication
* Ability to provide written informed consent

Exclusion Criteria

* Any significant diseases (other than HL) or clinically significant findings, including psychiatric and behavioral problems, medical history and/or physical examination findings that would preclude the subject from participating in the study
* History or clinical evidence of cnetral nervous system (CNS) HL
* Received allogeneic BMT
* Received growth factor support or transfusions to achieve hematology entry criteria (platelets, hemoglobin, absolute neutrophil count)
* Major surgery within 4 weeks prior to study entry
* Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation
* Known history of another primary malignancy that has not been in remission for at least 5 years. Non-melanoma skin cancer and cervical carcinoma in situ or squamous intraepithelial lesions (e.g., cervical intraepithelial neoplasia \[CIN\] or prostatic intraepithelial/intraductal neoplasia \[PIN\]) are allowed.
* Any active viral, bacterial, or systemic fungal infection within 4 weeks prior study entry
* Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV)
* Histry of significant chronic or recurrent infections requiring treatment
* Receiving systemic steroids exceeding 10 mg prednisone or equivalent, or unstable on steroid medication, during the 3 weeks immediately preceding enrollment
* Pregnant or breast-feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anas Younes, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Craig Moskowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status NOT_YET_RECRUITING

MD Anderson Cancer Center - Dept. of Lymphoma and Myeloma

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Fatai Osinowo, MD

Role: CONTACT

Phone: 713-578-4332

Email: [email protected]

Tad Iwan

Role: CONTACT

Phone: 713-578-4181

Email: [email protected]

Facility Contacts

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Bri-Anne Wilson

Role: primary

Sarah Alandra Weaver

Role: backup

Amanda Wedgewood, RN