Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer (NCT00003453) | Clinical Trial Compass
TerminatedPhase 2
Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer
Stopped: Slow enrollment
United States6 participantsStarted 1996-08-21
Plain-language summary
Current therapies for Stage IV adrenal gland cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Stage IV adrenal gland cancer
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV adrenal gland cancer.
Who can participate
Age range6 Months – 99 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed stage IV adrenal gland carcinoma that is unlikely to respond to existing therapy and for which no curative therapy exists
* Measurable disease by MRI or CT scan
* Tumor must be greater than 2 cm at the largest diameter for the lymph nodes located in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in the largest diameter for other localizations
PATIENT CHARACTERISTICS:
Age:
* 6 months and over
Performance status:
* Karnofsky 60-100%
Life expectancy:
* At least 2 months
Hematopoietic:
* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.5 mg/dL
* SGOT/SGPT no greater than 5 times upper limit of normal
* No hepatic failure
Renal:
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
* No severe heart disease
* No uncontrolled hypertension
* No history of congestive heart failure
* No history of other cardiovascular conditions that contraindicate high dosages of sodium
Pulmonary:
* No severe lung disease
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No serious active infections or fever
* No other concurrent serious disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy and recovered
* No concurrent immunomodulating agents
C…