Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

Gemcitabine Combined With Mistletoe in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Active 18 and over NCCAM, NCI, Other NCCAM-02-AT-260 NCI-02-AT-0260

Special Category: NIH Clinical Center trial

Objectives

1. Determine the maximum tolerated dose of gemcitabine and mistletoe in patients with advanced solid tumors.
2. Determine the toxic effects of this regimen in these patients.
3. Determine the pharmacokinetic effects of gemcitabine with and without mistletoe in these patients.
4. Determine tumor response in patients treated with this regimen.
5. Determine the time to neutrophil count recovery in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed metastatic, recurrent, or unresectable locally advanced solid tumor, including one of the following:
  • Breast or colorectal cancer that has failed first-line chemotherapy
  • Non-small cell lung cancer
  • Pancreatic Cancer



• No CNS metastases



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• No prior mistletoe

Chemotherapy

• See Disease Characteristics
• No prior gemcitabine
• More than 30 days since prior chemotherapy and recovered

Endocrine therapy

• More than 30 days since prior glucocorticosteroid therapy

Radiotherapy

• Recovered from prior radiotherapy

Surgery

• Recovered from prior surgery

Other

• At least 30 days since prior investigational agents
• No other concurrent investigational agents

Patient Characteristics:

Age

• 18 and over

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 2.0 mg/dL
• No clinically significant hepatic dysfunction

Renal

• Creatinine no greater than 2.5 mg/dL
• No clinically significant renal dysfunction

Other

• Not pregnant or nursing
• Negative pregnancy test
• HIV negative
• No clinically significant unrelated illness (e.g., serious infection or organ dysfunction) that would preclude study tolerance

Projected Accrual

A total of 45-51 patients will be accrued for this study.

Outline

This is an open-label, dose-escalation study.

Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and mistletoe subcutaneously daily starting on day 8 of course 1. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Patients receive escalating doses of gemcitabine and mistletoe in 2 stages.

• Stage I: Cohorts of 3-6 patients receive escalating doses of mistletoe in combination with a constant dose of gemcitabine until the maximum tolerated dose (MTD) of mistletoe is determined.



• Stage II: Cohorts of 3-6 patients receive escalating doses of gemcitabine in combination with the MTD of mistletoe as determined in stage I until the MTD of gemcitabine is determined.

In both stages, the MTD is defined as the dose preceding that at which 2 patients experience dose-limiting toxicity.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

National Center for Complementary and Alternative Medicine

Patrick Mansky, MD, Principal investigator		Ph: 301-435-4845 Email: manskyp@mail.nih.gov

U.S.A.
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
		Patient Recruitment	Ph:  800-411-1222

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