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Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00005038
Recruitment Status : Unknown
Verified June 2001 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : September 20, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE April 6, 2000
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date September 20, 2013
Study Start Date  ICMJE June 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00005038 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Metastatic Kidney Cancer
Official Title  ICMJE A Randomized Phase II Study to Evaluate the Efficacy of Combined Immunotherapy With Subcutaneous Interleukin-2 and Maxamine in Patients With Metastatic Renal Cell Carcinoma
Brief Summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. Histamine dihydrochloride may prolong survival and improve quality of life in patients with metastatic kidney cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have metastatic kidney cancer.

Detailed Description

OBJECTIVES:

  • Determine the clinical efficacy and safety of subcutaneous (SC) histamine dihydrochloride given in conjunction with SC recombinant human interleukin-2 in patients with stage IV renal cell carcinoma in terms of survival at 1 year, objective tumor response rate, duration of response, and median survival.

OUTLINE: This is a randomized, open label study. Patients are randomized to receive interleukin-2 (IL-2) with or without histamine dihydrochloride.

  • Arm I: Patients receive IL-2 subcutaneously (SC) once daily and histamine dihydrochloride SC twice daily on days 1-5 of weeks 1-3 followed by 2 weeks of rest.
  • Arm II: Patients receive IL-2 as in arm I. Treatment continues for a minimum of 2 courses in both arms in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Cancer
Intervention  ICMJE
  • Biological: aldesleukin
  • Drug: histamine dihydrochloride
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic renal cell carcinoma
  • Bidimensionally measurable disease
  • No clinical evidence of CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Hemoglobin greater than 10.0 g/dL
  • WBC greater than 3,000/mm3
  • Platelet count greater than 100,000/mm3

Hepatic:

  • PTT normal
  • Bilirubin less than 1.25 times upper limit of normal (ULN)

Renal:

  • Creatinine less than 1.5 times ULN

Cardiovascular:

  • No abnormal cardiac function by resting ECG

Pulmonary:

  • FEV and FVC at least 70% predicted
  • SaO2 at least 90% by pulse oximetry

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No clinically significant acute viral, bacterial, or fungal infection requiring specific therapy
  • No pheochromocytoma
  • No glaucoma
  • No other concurrent ongoing active malignancy except carcinoma in situ of the cervix or localized squamous or basal cell carcinoma of the skin
  • No serious recent nonmalignant medical complication that would preclude study therapy
  • No organ grafts except skin grafts, blood transfusions, or bone marrow or stem cell transplantation
  • No prior documented asthma or systemic allergic reaction within past 5 years
  • No history of seizures, CNS disorders, or psychiatric disability that would preclude study compliance
  • No medical, sociologic, or psychological impediment that would preclude study compliance
  • No active peptic or esophageal ulcer disease
  • No prior peptic or esophageal ulcer disease with history of bleeding
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin)
  • No concurrent chemotherapy

Endocrine therapy:

  • At least 24 hours since prior steroids
  • No concurrent steroids including steroid therapy for documented adrenal failure or septic shock
  • Concurrent noncorticosteroid hormones for nonmalignancy conditions allowed

Radiotherapy:

  • At least 4 weeks since prior extensive radiotherapy
  • No concurrent radiotherapy to measurable malignant masses

Surgery:

  • Not specified

Other:

  • At least 24 hours since prior beta blockers or clonidine
  • No other concurrent systemic antimalignancy therapy
  • No other concurrent antitumor agents
  • No other concurrent investigational agents
  • No concurrent beta blockers or clonidine
  • No concurrent H2 receptor antagonists (e.g., Zantac, Tagamet) (arm I only)
  • No concurrent antihistamines except to treat acute colds or allergy symptoms
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00005038
Other Study ID Numbers  ICMJE CDR0000067627
CHNT-IL2-MAXAMINE
EU-99048
MAXIM-MP-502
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE The Christie NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mark R. Middleton, MD, PhD, MBChB, MRCP The Christie NHS Foundation Trust
PRS Account National Cancer Institute (NCI)
Verification Date June 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP