Clinical trial NCT00003514: Antineoplaston Therapy in Treating Patients With Neuroendocrine Tumor That Is Metastatic or Unlikely to Respond to Surgery or Radiation Therapy
Official title: Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Metastatic or Incurable Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Merkel Cell Carcinoma
Islet Cell Carcinoma
Neuroendocrine Carcinoma
Pituitary Tumor
Keywords: ACTH-producing pituitary tumor
prolactin-producing pituitary tumor
growth hormone-producing pituitary tumor
recurrent pituitary tumor
TSH producing pituitary tumor
nonfunctioning pituitary tumor
somatostatinoma
stage III Merkel cell carcinoma
recurrent Merkel cell carcinoma
neuroendocrine carcinoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

Detailed description: OBJECTIVES:

* Provide treatment with antineoplastons A10 and AS2-1 for patients with metastatic or incurable neuroendocrine tumors.
* Describe response, tolerance to, and side effects of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive gradually escalating doses of antineoplastons A10 and AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached.

Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR.

Tumors are measured every 2 months for 1 year and then every 3 months for 1 year.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Eligibility criteria: 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 since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

* Concurrent corticosteroids allowed

Radiotherapy:

* At least 8 weeks since prior radiotherapy

Surgery:

* Recovered from prior surgery

Other:

* Prior cytodifferentiating agents allowed
* No prior antineoplastons
* No other concurrent antineoplastic agents

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Burzynski Clinic
state: Texas
Study officials:
affiliation: Burzynski Research Institute
name: Stanislaw R. Burzynski, MD, PhD
role: STUDY_CHAIR
References: