Clinical trial · Interventional

Trastuzumab and Interleukin-2 in Treating Patients With Metastatic Breast Cancer

Phase II Trial of Anti-HER-2 Monoclonal Antibody Trastuzumab (Herceptin) in Combination With Low Dose Interleukin-2 (Proleukin) in Metastatic Breast Cancer Patients Who Have Previously Failed Trastuzumab

NCT00006228CI-TRIAL-00012340completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill breast cancer cells. Phase II trial to study the effectiveness of trastuzumab plus interleukin-2 in treating patients who have metastatic breast cancer that has not responded to previous trastuzumab therapy.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
HER2-positive Breast Cancer	HER2-Positive Breast Carcinoma	ALIAS	0.90
Male Breast Cancer	Male Breast Carcinoma	ALIAS	0.90
Recurrent Breast Cancer	Malignant Breast Neoplasm	CURATED_BROADER	0.78
Stage IV Breast Cancer	Malignant Breast Neoplasm	CURATED_BROADER	0.78

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
aldesleukin	Biological	Aldesleukin	ALIAS
laboratory biomarker analysis	Other	—	UNRESOLVED
pharmacological study	Other	—	UNRESOLVED
trastuzumab	Biological	Trastuzumab	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Treatment (trastuzumab and aldesleukin)
description
Patients receive trastuzumab IV over 30-90 minutes on days 1 and 8 and aldesleukin SC on days 2-7 and 9-21. Beginning on day 22, patients receive trastuzumab IV over 30 minutes every 14 days. Patients also receive aldesleukin SC daily on days 1-14. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
interventionNames
1. Biological: trastuzumab
2. Biological: aldesleukin
3. Other: laboratory biomarker analysis
4. Other: pharmacological study

Primary outcomes (2)

measure
Response rate using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame
Up to 12 months
measure
Toxicity assessed using Common Toxicity Criteria (CTC) version 2.0
timeFrame

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer

  * Primary and/or metastatic disease
* HER2 overexpression 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)

  * Tumors with HER2 2+ overexpression by IHC allowed if confirmed by FISH
* Progressive disease during or within 12 months of receiving prior regimen containing trastuzumab (Herceptin)
* Unidimensionally measurable disease

  * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  * The following are not considered measurable:

    * Bone metastases
    * Pleural or peritoneal effusion
    * Ascites
    * Leptomeningeal disease
    * Lymphangitic disease
    * Inflammatory breast cancer
    * Cystic lesions
    * CNS lesions
* CNS metastases allowed if all of the following conditions are met:

  * Asymptomatic
  * At least 3 months since prior surgery and/or cranial irradiation
  * At least 3 weeks since prior steroids
* Hormone receptor status:

  * Not specified
* Male or female
* Performance status - ECOG 0-2
* Granulocyte count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT and SGPT no greater than 2 times ULN (5 times ULN for liver metastases)
* Alkaline phosphatase no greater than 2 times ULN (5 times ULN for liver metastases)
* Creatinine no greater than 1.5 times ULN
* LVEF at least lower limit of normal by MUGA or echocardiogram
* No congestive heart failure or active ischemic heart disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No psychiatric illness, medical condition, or uncontrolled infection that would preclude study
* No underlying immunodeficiency (e.g., HIV or autoimmune disease)
* No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
* See Disease Characteristics
* Prior cumulative doxorubicin dose no greater than 360 mg/m\^2
* At least 3 weeks since prior chemotherapy
* No more than 2 prior chemotherapy regimens for metastatic disease
* No concurrent chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior endocrine therapy
* No concurrent corticosteroids or dexamethasone
* Concurrent hormones allowed for conditions unrelated to disease (e.g., insulin for diabetes)
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy
* No prior radiotherapy to study lesion, unless evidence of disease progression
* No concurrent palliative radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior major surgery
* No concurrent immunosuppressive drugs

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jul 1, 2000
Primary completion: Jul 1, 2003
Completion: —
First posted: Jan 27, 2003
Last update posted: Oct 8, 2013
Enrollment: 37 (estimated)
Lead sponsor: National Cancer Institute (NCI) NIH

Data updated 22 days agoSource updated Oct 8, 2013source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.