Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001249
Other study ID # 900043
Secondary ID 90-C-0043
Status Completed
Phase Phase 1
First received November 3, 1999
Last updated March 3, 2008
Start date December 1989
Est. completion date October 2000

Study information

Verified date November 1999
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL).


Description:

The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL). This study represents an extension of phase I trial (Clinical Project #90-C-0043, FDA IND #3469) which permitted the administration of 5 mCi, 10 mCi, and 15mCi 90Y-anti-Tac to patients with ATL. We propose to administer 90Y-anti-Tac (10 mCi doses) to patients with Tac-expressing ATL who are over 18 years of age and who fill the patient eligibility criteria.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

Histologically confirmed adult T-cell leukemia/lymphoma (ATL) or cutaneous T-cell lymphoma (CTCL).

Reactivity of at least 10% of peripheral blood, lymph node, or dermal malignant cells with anti-Tac as determined by immunofluorescent staining or soluble IL-2 receptor level greater than 1,500 U required.

All stages of Tac-expressing T-cell leukemia and lymphoma eligible except Stage I CTCL.

All forms of ATL eligible, including the "smoldering" type as well as aggressive disease.

No symptomatic CNS disease other than tropical spastic paraparesis.

Asymptomatic CNS disease with demonstrable malignant cells in the CSF allowed (such patients receive CNS therapy, e.g., intrathecal methotrexate and/or CNS irradiation, as appropriate).

PRIOR/CONCURRENT THERAPY:

Biologic Therapy: Not specified.

Chemotherapy:

CTCL must have failed initial chemotherapy.

ATL may or may not have had prior chemotherapy.

At least 4 weeks since prior cytotoxic chemotherapy.

Endocrine Therapy: Not specified.

Radiotherapy: At least 4 weeks since prior radiotherapy.

Surgery: Not specified.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance status: Not specified.

Life expectancy: Greater than 1 month.

Hematopoietic: WBC at least 3,000, Platelets at least 75,000.

Hepatic: Not specified.

Renal: Not specified.

Other:

No pregnant women.

Negative pregnancy test required of fertile women.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment


Intervention

Drug:
Yttrium-90 radiolabeled anti-Tac antibody


Locations

Country Name City State
United States National Cancer Institute (NCI) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kozak RW, Raubitschek A, Mirzadeh S, Brechbiel MW, Junghans RP, Gansow OA, Waldmann TA. Nature of the bifunctional chelating agent used for radioimmunotherapy with yttrium-90 monoclonal antibodies: critical factors in determining in vivo survival and organ toxicity. Cancer Res. 1989 May 15;49(10):2639-44. Erratum in: Cancer Res 1999 Oct 15;59(20):5400. Junghaus R [corrected to Junghans RP]. — View Citation

Waldmann TA, Goldman CK, Bongiovanni KF, Sharrow SO, Davey MP, Cease KB, Greenberg SJ, Longo DL. Therapy of patients with human T-cell lymphotrophic virus I-induced adult T-cell leukemia with anti-Tac, a monoclonal antibody to the receptor for interleukin-2. Blood. 1988 Nov;72(5):1805-16. — View Citation

See also
  Status Clinical Trial Phase
Terminated NCT03357224 - PARCT: Trial of Atezolizumab in Relapsed/Refractory Cutaneous T Cell Lymphoma (CTCL) Phase 2
Completed NCT02567656 - Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma Phase 1
Completed NCT00051012 - Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients Phase 4
Recruiting NCT03646422 - AEDV Registry of Primary Cutaneous Lymphoma
Terminated NCT03789864 - Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides N/A
Active, not recruiting NCT04998331 - A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin
Active, not recruiting NCT02953301 - Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) Phase 2
Completed NCT01486277 - A Study of the Histone Deacetylase Inhibitor (HDACi) Quisinostat (JNJ-26481585) in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma Phase 2
Completed NCT01433731 - Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL) Phase 1
Completed NCT05137847 - A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
Active, not recruiting NCT03902184 - IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma Phase 2
Completed NCT00896493 - Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma Phase 2
Completed NCT00211198 - Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL) Phase 4
Terminated NCT03601819 - Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders Phase 1
Withdrawn NCT03742804 - Study Of Intratumoral G100 In Cutaneous T Cell Lymphoma Phase 2
Completed NCT02836886 - VircapSeq Virus Detection in Sézary Syndrome
Completed NCT00050999 - Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients Phase 4
Terminated NCT02323659 - Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas Phase 4
Recruiting NCT02840747 - Tissue Repository: CTCL Collection Protocol
Completed NCT03192202 - AFM13 in Relapsed/Refractory Cutaneous Lymphomas Phase 1/Phase 2