Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma
HeFi-1 Antibody Therapy in Ki-1 and Hodgkin's Lymphomas, a Phase I Study
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients with refractory anaplastic large cell lymphoma or Hodgkin's lymphoma.
Panoramica dello studio
Descrizione dettagliata
OBJECTIVES:
- Determine the safety and tolerability of multiple doses of monoclonal antibody HeFi-1 in patients with CD30+ anaplastic large cell lymphoma or Hodgkin's lymphoma.
- Determine the pharmacokinetics of this drug in this patient population.
- Evaluate the efficacy, in terms of correlating immunologic parameters and immunogenicity, of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive monoclonal antibody HeFi-1 IV over 30 minutes 3 times a week for 2 weeks. Treatment may continue for 2 additional weeks in the absence of anti-HeFi-1 response. Responding patients may continue treatment at monthly intervals for one year.
Cohorts of 3-4 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 2 of 4 patients experience dose-limiting toxicity.
Patients are followed monthly.
PROJECTED ACCRUAL: A total of 9 patients will be accrued for this study.
Tipo di studio
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02215
- Beth Israel Deaconess Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
DISEASE CHARACTERISTICS:
Histologically confirmed CD30+ anaplastic large cell lymphoma (ALCL) or Hodgkin's lymphoma
- At least 50% of malignant cells must react with HeFi-1
- HIV positive or HIV negative
- Measurable disease
- No symptomatic CNS disease
- Must have failed or be ineligible for standard chemotherapy regimen
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Not specified
Life expectancy:
- More than 2 months
Hematopoietic:
- Not specified
Hepatic:
- No significant hepatic disease
- Bilirubin no greater than 2 mg/dL
Renal:
- No significant renal disease
- Creatinine no greater than 3 mg/dL
Cardiovascular:
- No significant cardiovascular disease
Pulmonary:
- No significant pulmonary disease
Other:
- No significant endocrine, rheumatologic, or allergic disease
- No active clinical disease caused by cytomegalovirus (CMV), herpes simplex virus (HSV) I, HSV II, hepatitis B, or tuberculosis
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior murine antibody therapy
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy to measurable disease
Surgery:
- Not specified
Other
- At least 4 weeks since prior cytotoxic therapy to measurable disease
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Mascheramento: Nessuno (etichetta aperta)
Collaboratori e investigatori
Investigatori
- Cattedra di studio: Henry Koon, MD, Beth Israel Deaconess Medical Center
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema immunitario
- Neoplasie per tipo istologico
- Neoplasie
- Malattie linfoproliferative
- Malattie linfatiche
- Disturbi immunoproliferativi
- Linfoma non Hodgkin
- Linfoma, cellule T
- Linfoma
- Malattia di Hodgkin
- Linfoma, a grandi cellule, anaplastico
- Effetti fisiologici delle droghe
- Fattori immunologici
- Anticorpi
- Anticorpi, monoclonali
Altri numeri di identificazione dello studio
- BIDMC-97127
- CDR0000066859 (Identificatore di registro: PDQ (Physician Data Query))
- NEDH-97127
- NCI-870
- NCI-V99-1515
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su monoclonal antibody HeFi-1
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National Cancer Institute (NCI)Completato