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Anti-Tac(90 Y-HAT) to Treat Hodgkin's Disease, Non-Hodgkin's Lymphoma and Lymphoid Leukemia

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ClinicalTrials.gov Identifier: NCT00001575
Recruitment Status : Completed
First Posted : November 4, 1999
Results First Posted : December 7, 2015
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Thomas Waldmann, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hodgkin's Disease
Lymphoma, Non-Hodgkin
Interventions Biological: Y-90 Humanized Anti-Tac
Drug: Calcium-DTPA
Enrollment 87
Recruitment Details  
Pre-assignment Details All ph I pts who received an initial bone marrow transplantation received an initial dose of 10mCi followed by 15mCi. At the discretion of the PI on the basis of persistent reduced hematopoietic values, a subsequent dose may have been reduced from 15mCi to 10mCi or 5mCi. All ph II pts received at least one dose of 10mCi and/or 15mCi, or 20mCi.
Arm/Group Title Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
Hide Arm/Group Description

10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).

Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body

Period Title: Overall Study
Started 87
Treated 65
Completed 42
Not Completed 45
Reason Not Completed
Screening failures-Ph I portion             22
Withdrawn/deaths             23
Arm/Group Title Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
Hide Arm/Group Description

10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).

Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body

Overall Number of Baseline Participants 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants
<=18 years
0
   0.0%
Between 18 and 65 years
70
  80.5%
>=65 years
17
  19.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants
36  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants
Female
34
  39.1%
Male
53
  60.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants
Hispanic or Latino
6
   6.9%
Not Hispanic or Latino
81
  93.1%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   1.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
15
  17.2%
White
66
  75.9%
More than one race
0
   0.0%
Unknown or Not Reported
5
   5.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 87 participants
87
1.Primary Outcome
Title Maximum Tolerated Dose (MTD) of 90Y-HAT
Hide Description Phase I portion maximum tolerated dose (MTD) is defined as the dose level below the dose at which 2 out of 2-6 patients develop DLT (if any patient develops grade IV toxicity of any type (excluding grade IV neutropenia) or grade III non-hematologic toxicity that patient may not continue on the study at the same dose level and therefore has had a dose limiting toxicity). There can be no more than 1 out of 6 patients with DLT at the MTD. The MTD will be assessed using only the results from the first cycle of therapy.
Time Frame Patients could receive 90Y-HAT 15mCi per cycle and complete up to a maximum of 7 doses or 2 doses by the average of every 6 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Phase I portion-maximum tolerated dose. Only the Hodgkin's participants was analyzed (i.e., 28).
Arm/Group Title Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
Hide Arm/Group Description:

10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).

Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: mci
15
2.Primary Outcome
Title Clinical Response
Hide Description Clinical Response of patient is measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Tumor responses were evaluated by In-HAT imaging (i.e., simultaneous with administration of therapeutic 90Y-daclizumab), Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scans and computed tomography (CT) scans. Complete response is a disappearance of all measurable and evaluable disease lasting more than I month. Partial response is a reduction by ≥ 50% of leukemic cell count or ≥ 50% reduction in the size of all measurable lesions, and no increase in size of any measurable or evaluable lesion or appearance of new lesions for 1 month. Stable disease is less than partial response with no more than a 25% increase in leukemic cell count, no new lesions, or less than a 25% increase in any measurable lesion. Progressive disease is at least a 25% increase in leukemic cell count, appearance of new lesions, or an increase of 25% or greater in any measurable lesion after 2 weeks.
Time Frame Patient would be measured with computed tomography (CT) scan, Fludeoxyglucose (18F) positron-emission tomography (FDG PET) scan in 28 days before treatment. Patient would be evaluated with In-HAT imaging at Day 1,4,5,6 and Day 7 in week 1 of each cycle.
Hide Outcome Measure Data
Hide Analysis Population Description
Phase II portion. Only the Hodgkin's participants was analyzed (i.e., added more Hodgkins participants to study).
Arm/Group Title Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
Hide Arm/Group Description:

10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).

Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body

Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: participants
Complete Response 14
Partial Response 9
Stable Disease 14
Progressive Disease 9
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 16 yrs 18 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
Hide Arm/Group Description:

10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).

Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body

Overall Number of Participants Analyzed 64
Measure Type: Number
Unit of Measure: participants
57
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
Hide Arm/Group Description

10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).

Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body

All-Cause Mortality
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
Affected / at Risk (%) # Events
Total   8/64 (12.50%)    
Blood and lymphatic system disorders   
BLOOD/BONE MARROW:: Bone marrow cellularity  1  1/64 (1.56%)  1
Cardiac disorders   
CARDIOVASCULAR (GENERAL):: Hypotension  1  1/64 (1.56%)  1
Gastrointestinal disorders   
PAIN:: Abdominal pain or cramping  1  1/64 (1.56%)  1
General disorders   
Multi-organ failure  1  1/64 (1.56%)  1
PAIN:: Pain-Other (Specify, tooth pain)  1  1/64 (1.56%)  1
Hepatobiliary disorders   
HEPATIC:: Liver dysfunction/failure (clinical)  1  1/64 (1.56%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Secondary Malignancy-Other (Specify,____) excludes metastasis from initial primary  1 [1]  3/64 (4.69%)  3
Secondary Malignancy-Other (Specify,____) excludes metastasis from initial primary  1 [2]  1/64 (1.56%)  1
Secondary Malignancy-Other (Specify,____) excludes metastasis from initial primary  1 [3]  1/64 (1.56%)  1
SYNDROMES:: Syndromes-Other (Specify, MDS)  1  1/64 (1.56%)  1
Respiratory, thoracic and mediastinal disorders   
PULMONARY:: Pulmonary-Other (Specify, respiratory failure)  1  1/64 (1.56%)  1
PULMONARY:: Hypoxia  1  1/64 (1.56%)  1
PULMONARY:: Pneumonitis/pulmonary infiltrates  1  1/64 (1.56%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v3
[1]
MDS
[2]
MDS/AML
[3]
myelodysplastic syndrome
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)
Affected / at Risk (%) # Events
Total   49/64 (76.56%)    
Blood and lymphatic system disorders   
BLOOD/BONE MARROW:: Hemoglobin  1  33/64 (51.56%)  109
BLOOD/BONE MARROW:: Leukocytes (total WBC)  1  32/64 (50.00%)  132
BLOOD/BONE MARROW:: Lymphopenia  1  37/64 (57.81%)  142
BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)  1  15/64 (23.44%)  64
BLOOD/BONE MARROW:: Platelets  1  37/64 (57.81%)  115
BLOOD/BONE MARROW:: Transfusion: Platelets  1  1/64 (1.56%)  1
COAGULATION:: Partial thromboplastin time (PTT)  1  10/64 (15.63%)  19
COAGULATION:: Prothrombin time (PT)  1  6/64 (9.38%)  12
Cardiac disorders   
CARDIOVASCULAR (ARRHYTHMIA):: Prolonged QTc interval (QTc > 0.48 seconds)  1  1/64 (1.56%)  1
CARDIOVASCULAR (ARRHYTHMIA):: Sinus bradycardia  1  1/64 (1.56%)  1
CARDIOVASCULAR (ARRHYTHMIA):: Sinus tachycardia  1  1/64 (1.56%)  1
CARDIOVASCULAR (ARRHYTHMIA):: Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)  1  1/64 (1.56%)  3
CARDIOVASCULAR (GENERAL):: Edema  1  4/64 (6.25%)  4
CARDIOVASCULAR (GENERAL):: Hypotension  1  10/64 (15.63%)  15
Ear and labyrinth disorders   
AUDITORY/HEARING:: Auditory/Hearing-Other (Specify, pressure in right ear)  1  1/64 (1.56%)  1
Endocrine disorders   
ENDOCRINE:: Hot flashes/flushes  1  1/64 (1.56%)  1
ENDOCRINE:: Hypothyroidism  1  1/64 (1.56%)  1
Eye disorders   
OCULAR/VISUAL:: Ocular/Visual-Other (Specify, transient vision lost)  1  1/64 (1.56%)  1
Gastrointestinal disorders   
GASTROINTESTINAL:: Anorexia  1  4/64 (6.25%)  4
GASTROINTESTINAL:: Constipation  1  5/64 (7.81%)  5
GASTROINTESTINAL:: Dehydration  1  1/64 (1.56%)  1
GASTROINTESTINAL:: Diarrhea patients without colostomy  1  4/64 (6.25%)  5
GASTROINTESTINAL:: Dyspepsia/heartburn  1  5/64 (7.81%)  5
GASTROINTESTINAL:: Dysphagia, esophagitis, odynophagia (painful swallowing)  1  2/64 (3.13%)  2
GASTROINTESTINAL:: Gastrointestinal-Other (Specify, tongue discoloration)  1  1/64 (1.56%)  1
GASTROINTESTINAL:: Mouth dryness  1  1/64 (1.56%)  1
GASTROINTESTINAL:: Nausea  1  15/64 (23.44%)  21
GASTROINTESTINAL:: Taste disturbance (dysgeusia)  1  1/64 (1.56%)  1
GASTROINTESTINAL:: Vomiting  1  12/64 (18.75%)  15
HEMORRHAGE:: Rectal bleeding/hematochezia  1  1/64 (1.56%)  1
PAIN:: Abdominal pain or cramping  1  7/64 (10.94%)  8
General disorders   
CONSTITUTIONAL SYMPTOMS:: Fatigue (lethargy, malaise, asthenia)  1  8/64 (12.50%)  9
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)  1 [1]  18/64 (28.13%)  37
CONSTITUTIONAL SYMPTOMS:: Rigors, chills  1  5/64 (7.81%)  6
CONSTITUTIONAL SYMPTOMS:: Weight loss  1  1/64 (1.56%)  1
PAIN:: Pain-Other (Specify, ankle)  1  1/64 (1.56%)  1
PAIN:: Pain-Other (Specify, Back)  1  1/64 (1.56%)  1
PAIN:: Pain-Other (Specify, jaw pain/tightness)  1  1/64 (1.56%)  1
PAIN:: Pain-Other (Specify, pain Lt axilla surgical site)  1  1/64 (1.56%)  1
PAIN:: Pain-Other (Specify, pain: Back:sacral area)  1  1/64 (1.56%)  1
PAIN:: Pain-Other (Specify, Rt shoulder pain)  1  1/64 (1.56%)  1
PAIN:: Pain-Other (Specify, Rt great toe pain: ingrown toenail)  1  1/64 (1.56%)  1
PAIN:: Pain-Other (Specify, Rt flank)  1  1/64 (1.56%)  1
Hepatobiliary disorders   
HEPATIC:: Alkaline phosphatase  1  12/64 (18.75%)  25
HEPATIC:: Bilirubin  1  12/64 (18.75%)  26
HEPATIC:: Hypoalbuminemia  1  31/64 (48.44%)  76
HEPATIC:: SGOT (AST) (serum glutamic oxaloacetic transaminase)  1  16/64 (25.00%)  33
HEPATIC:: SGPT (ALT) (serum glutamic pyruvic transaminase)  1  16/64 (25.00%)  23
Immune system disorders   
ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever)  1  1/64 (1.56%)  1
ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  2/64 (3.13%)  2
ALLERGY/IMMUNOLOGY:: Allergy-Other (Specify, sinus congestion)  1  1/64 (1.56%)  1
Infections and infestations   
INFECTION/FEBRILE NEUTROPENIA:: Catheter-related infection  1  1/64 (1.56%)  1
INFECTION/FEBRILE NEUTROPENIA:: Infection without neutropenia  1  11/64 (17.19%)  17
Metabolism and nutrition disorders   
METABOLIC/LABORATORY:: Amylase  1  3/64 (4.69%)  3
METABOLIC/LABORATORY:: Bicarbonate  1  1/64 (1.56%)  1
METABOLIC/LABORATORY:: CPK (creatine phosphokinase)  1  6/64 (9.38%)  7
METABOLIC/LABORATORY:: Hypercalcemia  1  3/64 (4.69%)  5
METABOLIC/LABORATORY:: Hypercholesterolemia  1  6/64 (9.38%)  9
METABOLIC/LABORATORY:: Hyperglycemia  1  12/64 (18.75%)  19
METABOLIC/LABORATORY:: Hyperkalemia  1  5/64 (7.81%)  5
METABOLIC/LABORATORY:: Hypermagnesemia  1  7/64 (10.94%)  11
METABOLIC/LABORATORY:: Hypernatremia  1  3/64 (4.69%)  5
METABOLIC/LABORATORY:: Hypertriglyceridemia  1  3/64 (4.69%)  3
METABOLIC/LABORATORY:: Hyperuricemia  1  3/64 (4.69%)  4
METABOLIC/LABORATORY:: Hypocalcemia  1  12/64 (18.75%)  21
METABOLIC/LABORATORY:: Hypoglycemia  1  4/64 (6.25%)  4
METABOLIC/LABORATORY:: Hypokalemia  1  5/64 (7.81%)  7
METABOLIC/LABORATORY:: Hypomagnesemia  1  18/64 (28.13%)  31
METABOLIC/LABORATORY:: Hyponatremia  1  15/64 (23.44%)  25
METABOLIC/LABORATORY:: Hypophosphatemia  1  7/64 (10.94%)  16
METABOLIC/LABORATORY:: Lipase  1  2/64 (3.13%)  5
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, low zinc)  1  34/64 (53.13%)  58
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, low zinc serum)  1  4/64 (6.25%)  7
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, serum zinc)  1  1/64 (1.56%)  1
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, zinc)  1  4/64 (6.25%)  11
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, zinc, low)  1  1/64 (1.56%)  1
METABOLIC/LABORATORY:: Metabolic/Laboratory-Other (Specify, zinc-serum (low))  1  1/64 (1.56%)  3
Musculoskeletal and connective tissue disorders   
MUSCULOSKELETAL:: Musculoskeletal-Other (Specify, Akathisia)  1  1/64 (1.56%)  1
MUSCULOSKELETAL:: Musculoskeletal-Other (Specify,muscle aches)  1  1/64 (1.56%)  1
MUSCULOSKELETAL:: Osteonecrosis (avascular necrosis)  1  1/64 (1.56%)  1
PAIN:: Arthralgia (joint pain)  1  3/64 (4.69%)  5
PAIN:: Bone pain  1  5/64 (7.81%)  6
PAIN:: Chest pain (non-cardiac and non-pleuritic)  1  3/64 (4.69%)  3
PAIN:: Myalgia (muscle pain)  1  10/64 (15.63%)  16
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
PAIN:: Tumor pain (onset or exacerbation of tumor pain due to treatment)  1  2/64 (3.13%)  2
Nervous system disorders   
NEUROLOGY:: Dizziness/lightheadedness  1  3/64 (4.69%)  3
NEUROLOGY:: Insomnia  1  3/64 (4.69%)  3
PAIN:: Headache  1  9/64 (14.06%)  13
Renal and urinary disorders   
HEMORRHAGE:: Hematuria (in the absence of vaginal bleeding)  1  1/64 (1.56%)  1
RENAL/GENITOURINARY:: Creatinine  1  4/64 (6.25%)  10
RENAL/GENITOURINARY:: Dysuria (painful urination)  1  1/64 (1.56%)  1
RENAL/GENITOURINARY:: Hemoglobinuria  1  2/64 (3.13%)  4
RENAL/GENITOURINARY:: Proteinuria  1  1/64 (1.56%)  2
RENAL/GENITOURINARY:: Renal/Genitourinary-Other (Specify, hesitancy)  1  1/64 (1.56%)  1
Reproductive system and breast disorders   
SEXUAL/REPRODUCTIVE FUNCTION:: Irregular menses (change from baseline)  1  1/64 (1.56%)  1
Respiratory, thoracic and mediastinal disorders   
PAIN:: Pleuritic pain  1  1/64 (1.56%)  1
PULMONARY:: Cough  1  8/64 (12.50%)  8
PULMONARY:: Dyspnea (shortness of breath)  1  3/64 (4.69%)  3
PULMONARY:: Hypoxia  1  2/64 (3.13%)  2
PULMONARY:: Pleural effusion (non-malignant)  1  2/64 (3.13%)  2
PULMONARY:: Pneumonitis/pulmonary infiltrates  1  1/64 (1.56%)  1
PULMONARY:: Pulmonary-Other (Specify, upper respiratory infection)  1  1/64 (1.56%)  1
Skin and subcutaneous tissue disorders   
DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify, eczematoid dermatitis)  1  1/64 (1.56%)  1
DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify, rash; erythematous, eczematous)  1  1/64 (1.56%)  1
DERMATOLOGY/SKIN:: Dermatology/Skin-Other (Specify, skin lesions)  1  1/64 (1.56%)  1
DERMATOLOGY/SKIN:: Flushing  1  1/64 (1.56%)  1
DERMATOLOGY/SKIN:: Pruritus  1  5/64 (7.81%)  5
DERMATOLOGY/SKIN:: Rash/desquamation  1  8/64 (12.50%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v3
[1]
CONSTITUTIONAL SYMPTOMS
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas Waldmann M.D.
Organization: National Cancer Institute
Phone: 301-496-6653
EMail: waldmann@nih.hhs.gov
Layout table for additonal information
Responsible Party: Thomas Waldmann, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001575    
Obsolete Identifiers: NCT00019305
Other Study ID Numbers: 970110
97-C-0110
First Submitted: November 3, 1999
First Posted: November 4, 1999
Results First Submitted: May 14, 2015
Results First Posted: December 7, 2015
Last Update Posted: December 7, 2015