Andy, Here's the protocol for the Targretin Head & Neck Phase I trial at MD Anderson in 1994. I don't recall any specifics on head and neck responses, but if I read the Washington DC report correctly, then the patient was treated several years ago, before the LGD1550 clinical began. I think that all three compounds (Targretin, Panretin, and ALRT1550) have been in trials at Lombardi and MD Anderson and Targretin is in advanced trials for prostate cancer.
Phase I Study of Daily Oral LGD1069 for Advanced, Recurrent Squamous
Cell Cancer of the Head and Neck
Summary Last Modified: 11/94
Protocol IDs: MDA-DM-94045, NCI-V94-0497
Protocol Type: treatment
Sponsorship: Other/Unknown
Status: Active
Age Range: over 18
PROJECTED ACCRUAL:
39 patients will be entered over 6 months.
OBJECTIVES:
I. Describe the toxicities and determine the dose-limiting toxicity and
maximum tolerated dose of daily oral LGD1069 in patients with advanced,
recurrent squamous cell cancer of the head and neck.
II. Describe the pharmacokinetics of LGD1069 and determine its metabolic fate.
II. Evaluate the clinical progression and outcome of patients with various
types of squamous cell cancer of the head and neck treated with LGD1069.
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Histologically confirmed, advanced, recurrent squamous cell
cancer of the head and neck
Measurable disease not required
No CNS lesions
--Prior/Concurrent Therapy--
No investigational therapy within 4 weeks
Recovered from reversible side effects of prior therapy
Permanent and stable changes acceptable
Biologic therapy:
Not specified
Chemotherapy:
No cytotoxic chemotherapy within 3 weeks of study entry
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
At least 21 days since major surgery
--Patient Characteristics--
Age:
Over 18
Performance status:
ECOG 0-2
Hematopoietic:
WBC at least 4,000
Platelets at least 100,000
Hb at least 9.0 g/dl
Hepatic:
PT/PTT normal
The following parameters no greater than 1.5 x ULN:
Bilirubin
SGOT/SGPT
LDH
Alkaline phosphatase
Renal:
Creatinine no greater than 1.5 x ULN OR
Creatinine clearance at least 60 ml/min/1.72 sqm
Cardiovascular:
No cardiomyopathy
Other:
Stable dosage of any drug affecting hepatic drug
metabolism/renal drug excretion
No initiation of such drug if possible
No illness that would preclude protocol treatment
No severe vomiting/anorexia/malnutrition
No recent history of weight loss greater than 10%
No pregnant or nursing women
Effective contraception required during and for 9 months
following completion of therapy
Patient/caretaker able to communicate routinely by telephone
PROTOCOL OUTLINE:
Single-Agent Chemotherapy. LGD1069.
WARNING:
Many protocols are potentially hazardous, are intended only 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 protocol should be consulted before using this protocol. Dose and
schedule modifications are required for patients who develop gastrointestinal,
hematologic, neurologic, and biochemical (renal, hepatic, etc.) and/or other
abnormalities after the administration of therapy. Additionally, Federal
regulations for the protection of human subjects require approval of clinical
trials by your local Institutional Review Board.
PARTICIPATING ORGANIZATIONS/INVESTIGATORS
Scott Michael Lippman, Chair, Ph: 713-792-0625
University of Texas - M.D. Anderson Cancer Center
Principal Investigator(s) |
