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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005038
First received: April 6, 2000
Last updated: September 19, 2013
Last verified: June 2001
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Biological: aldesleukin
Drug: histamine dihydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005038

Locations
United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 9BX
Sponsors and Collaborators
Christie Hospital NHS Foundation Trust
Investigators
Study Chair: Mark R. Middleton, MD, PhD, MBChB, MRCP Christie Hospital NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00005038     History of Changes
Other Study ID Numbers: CDR0000067627, CHNT-IL2-MAXAMINE, EU-99048, MAXIM-MP-502
Study First Received: April 6, 2000
Last Updated: September 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Histamine
Histamine phosphate
Aldesleukin
Interleukin-2
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antineoplastic Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 14, 2014