Phase I Study of Monoclonal Antibody HeFi-1 in Patients With Refractory CD30-Positive Lymphoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Related Information Registry Information
Alternate Title
Monoclonal Antibody Therapy in Treating Patients with Refractory Lymphoma
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase I
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Treatment
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Closed
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18 and over
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NCI
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NCI-03-C-0038 NCI-5750, 5750, NCT00048880
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Objectives - Determine the toxicity and maximum tolerated dose of monoclonal antibody HeFi-1 in patients with refractory CD30-positive lymphoma.
- Determine the frequency and time course of onset of development of human anti-mouse antibody in patients treated with this drug.
- Correlate clinical tumor response with in vitro tumor apoptosis induction and sIL2-R levels in patients treated with this drug.
- Determine the pharmacokinetics of this drug in these patients.
Entry Criteria Disease Characteristics:
- Histologically confirmed lymphoma that is refractory to standard therapy, including the following:
- Hodgkin's lymphoma
- Progressive disease after first-line chemotherapy
- Refused or ineligible for bone marrow transplantation
- No radiation therapy-only failure
- Systemic anaplastic large cell lymphoma
- Progressive disease after first-line chemotherapy
- Refused or ineligible for bone marrow transplantation
- Cutaneous T-cell lymphoma
- No stage Ia disease
- Progressive disease after first-line therapy
- HTLV-1-positive T-cell lymphoma
- No smoldering disease
- Must have progressive disease after initial therapy
- At least 30% of tumor cells must be CD30 positive by immunohistochemistry
- Measurable or evaluable disease
- No CNS disease
Prior/Concurrent Therapy:
Biologic therapy - See Disease Characteristics
- No prior murine monoclonal antibody therapy
- No other concurrent monoclonal antibody therapy
- No concurrent biological response modifiers
- No concurrent gammaglobulin
Chemotherapy - See Disease Characteristics
- At least 3 weeks since prior cytotoxic chemotherapy
- No concurrent investigational or approved anticancer chemotherapeutic agents
Endocrine therapy - At least 3 weeks since prior systemic steroids
- No concurrent systemic steroids
- Concurrent topical or inhaled steroids allowed
Radiotherapy - See Disease Characteristics
Surgery Other - No concurrent drugs that affect lymphocytes
- No other concurrent investigational anticancer drugs
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic - Granulocyte count at least 1,000/mm3
- Platelet count at least 50,000/mm3 (transfusion-independent)
Hepatic - Bilirubin no greater than 2.0 mg/dL
- SGOT and SGPT no greater than 2 times upper limit of normal
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal - Creatinine less than 2.0 mg/dL
- No significant renal disease
Cardiovascular - No significant cardiovascular disease
Pulmonary - No significant pulmonary disease
Other - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 weeks after study participation
- No significant rheumatologic disease
- No significant allergic disease
- No significant endocrine disease
- Human anti-mouse antibody negative
- HIV negative
Expected Enrollment 18A total of 18 patients will be accrued for this study. Outcomes Primary Outcome(s)Toxicity and maximum tolerated dose every month during study treatment then every month for 6 months after completion of study treatment
Secondary Outcome(s)Response rate every month during study treatment then every month for 6 months after completion of study treatment
Outline This is a dose-escalation, multicenter study. Patients receive monoclonal antibody HeFi-1 IV over 30-120 minutes on days 0, 3, 6, and 9. Treatment repeats every 28 days for up to 2 courses in the absence of unacceptable toxicity, a human mouse antibody concentration more than 250 ng/mL, or disease progression. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HeFi-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 1 month, every 3 months for 1 year, and then every 6 months thereafter.
Trial Contact Information
Trial Lead Organizations NCI - Center for Cancer Research-Medical Oncology ![](https://webarchive.library.unt.edu/eot2008/20081018050525im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081018050525im_/http://www.cancer.gov/images/spacer.gif) | ![](https://webarchive.library.unt.edu/eot2008/20081018050525im_/http://www.cancer.gov/images/spacer.gif) | John Janik, MD, Protocol chair | ![](https://webarchive.library.unt.edu/eot2008/20081018050525im_/http://www.cancer.gov/images/spacer.gif) | | ![](https://webarchive.library.unt.edu/eot2008/20081018050525im_/http://www.cancer.gov/images/spacer.gif) |
Related Information Web site for additional information
Registry Information | ![](https://webarchive.library.unt.edu/eot2008/20081018050525im_/http://www.cancer.gov/images/spacer.gif) | Official Title | | Phase I Study Of HeFi-1 In Refractory CD30-Positive Malignancy | ![](https://webarchive.library.unt.edu/eot2008/20081018050525im_/http://www.cancer.gov/images/spacer.gif) | Trial Start Date | | 2002-11-15 | ![](https://webarchive.library.unt.edu/eot2008/20081018050525im_/http://www.cancer.gov/images/spacer.gif) | Trial Completion Date | | 2008-05-31 (estimated) | ![](https://webarchive.library.unt.edu/eot2008/20081018050525im_/http://www.cancer.gov/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00048880 | ![](https://webarchive.library.unt.edu/eot2008/20081018050525im_/http://www.cancer.gov/images/spacer.gif) | Date Submitted to PDQ | | 2002-11-15 | ![](https://webarchive.library.unt.edu/eot2008/20081018050525im_/http://www.cancer.gov/images/spacer.gif) | Information Last Verified | | 2008-04-06 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |