Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlik⦠(NCT00003514) | Clinical Trial Compass
WithdrawnPhase 2
Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy
United States0
Plain-language summary
RATIONALE: Antineoplastons are naturally-occurring substances that may also be made in the laboratory. Antineoplastons may inhibit the growth of cancer cells.
PURPOSE: This phase II trial is studying how well antineoplaston therapy works in treating patients with neuroendocrine tumor that is metastatic or unlikely to respond to surgery or radiation therapy.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Histologically confirmed incurable neuroendocrine tumor that is unlikely to respond to existing therapy, meeting 1 of the following criteria:
* Metastatic disease
* Disease that is not curable with surgery or radiotherapy
* Measurable disease by MRI or CT scan
* Tumor must be at least 2 cm
PATIENT CHARACTERISTICS:
Age:
* 18 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 serious 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 concurrent 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 sincā¦