RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Gene therapy such as GEM 231 may inhibit the growth of cancer cells and make the tumor more sensitive to chemotherapy. PURPOSE: Phase I trial to study the effectiveness of combining docetaxel and GEM 231 in treating patients who have recurrent or refractory solid tumors.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: docetaxel  Drug: GEM 231	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the safety and maximum tolerated dose of docetaxel and GEM 231 in patients with recurrent or refractory solid tumors. II. Determine any preliminary antitumor activity of GEM 231 in this patient population.

PROTOCOL OUTLINE: This is a dose escalation study of GEM 231 and docetaxel. Patients receive docetaxel IV over 1 hour on day 1, immediately followed by GEM 231 IV over 2 hours on days 1, 4, 8, and 11. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated with escalating doses of GEM 231 and docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity. Patients are followed monthly for 3 months.

PROJECTED ACCRUAL: A maximum of 1 patient will be accrued per week for this study until the maximum tolerated dose is reached.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists
• Measurable or evaluable disease
• No CNS metastases that are untreated, associated with seizures, or require intravenous medication and/or hospitalization

--Prior/Concurrent Therapy--

• Biologic therapy: At least 1 week since prior transfusion; Prior biologic therapy allowed and recovered; No other concurrent biologic therapy
• Chemotherapy: Prior chemotherapy allowed and recovered; No other concurrent chemotherapy
• Endocrine therapy: Prior hormonal therapy allowed and recovered; Concurrent palliative hormonal therapy allowed
• Radiotherapy: Prior radiotherapy allowed and recovered; No concurrent radiotherapy (except palliative)
• Surgery: At least 2 weeks since prior major surgery with wound complications
• Other: At least 2 weeks since prior investigational drugs; No other investigational drugs during or within 28 days of study; No concurrent CYP-3A metabolism dependent drugs

--Patient Characteristics--

• Age: 18 and over
• Performance status: WHO 0-2
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 8.5 g/dL
• Hepatic: Bilirubin no greater than upper limit of normal (ULN), except Gilbert's syndrome; PT and aPTT normal; SGOT or SGPT less than 3 times ULN
• Renal: Creatinine less than 1.25 times ULN; No renal tubular dysfunction (i.e., at least 2+ proteinuria within the past 2 weeks)
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception for 1 month prior to, during, and 3 months after study; No other serious medical condition that would prevent compliance; No serious infection; Adequate venous access; No known hypersensitivity to docetaxel or any oligodeoxynucleotides; No prior peripheral neuropathy greater than grade 2; No psychological or geographical condition that would prevent compliance

New York
      Albert Einstein Comprehensive Cancer Center, Bronx,  New York,  10461,  United States

Study chairs or principal investigators

Sridhar Mani,  Study Chair,  Albert Einstein Cancer Research Center   

Study ID Numbers:  CDR0000067520; AECM-1199906197; NCI-G00-1666; HYBRIDON-231-100A
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004864
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08