Antineoplaston Therapy in Treating Patients With Cancer of Unknown Primary Origin (NCT00003526) | Clinical Trial Compass
TerminatedPhase 2
Antineoplaston Therapy in Treating Patients With Cancer of Unknown Primary Origin
Stopped: Slow accrual
United States8 participantsStarted 1996-03-18
Plain-language summary
Current therapies for Cancer of Unknown Primary Origin provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Cancer of Unknown Primary Origin.
PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Cancer of Unknown Primary Origin.
Who can participate
Age range6 Months – 99 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of unknown primary that is unlikely to respond to existing therapy, including surgery, radiotherapy, and chemotherapy
* Evidence of tumor by MRI, CT scan, chest x-ray, or radionuclide scan
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:
* No hepatic insufficiency
* Bilirubin no greater than 2.5 mg/dL
* SGOT and SGPT no greater than 5 times upper limit of normal
Renal:
* No renal insufficiency
* Creatinine no greater than 2.5 mg/dL
* No history of renal conditions that contraindicate high dosages of sodium
Cardiovascular:
* 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, such as chronic obstructive pulmonary disease
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 4 weeks after study participation
* No active infection
* No nonmalignant systemic disease
* Not a high medical or psychiatric risk
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 4 weeks since prior immunotherapy
* No concurrent immunomodulating agents
Chemotherapy:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therap…
What they're measuring
1
Number of Participants With Objective Response or Stable Disease