A Phase I Study of Indenoisoquinolines LMP400 and LMP776 in Adults With Relapsed Solid Tumors and Lymphomas

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed relapsed solid tumor malignancy or Hodgkin or non-Hodgkin
lymphoma

- Metastatic or unresectable disease for which standard curative measures do not
exist or are associated with minimal patient survival benefit

- Measurable or evaluable disease

- Disease amenable to biopsy

- No known brain metastases

- Patients whose brain metastases have remained stable for ≥ 2 months after
treatment AND do not require steroids or anti-seizure medications may be
eligible at the discretion of the investigator

PATIENT CHARACTERISTICS:

- ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%

- Life expectancy > 3 months

- ANC ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Total bilirubin ≤ 1.5 mg/dL (≤ 2.5 mg/dL for patients with Gilbert's syndrome)

- AST and ALT ≤ 2.5 times upper limit of normal (ULN)

- Creatinine < 1.5 times ULN OR creatinine clearance ≥ 60 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception prior to, during, and for ≥ 2
months after completion of study therapy

- Willing to undergo skin biopsies

- No clinically significant illness that could compromise participation in the study,
including, but not limited to any of the following:

- Active or uncontrolled infection

- Immune deficiencies

- Known HIV infection requiring antiretroviral therapy

- Hepatitis B or C

- Uncontrolled diabetes

- Uncontrolled hypertension

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Myocardial infarction within the past 6 months

- Uncontrolled cardiac arrhythmia

- Psychiatric illness and/or social situation that would limit compliance with
study requirements

PRIOR CONCURRENT THERAPY:

- More than 4 weeks since prior chemotherapy or biological therapy (6 weeks for
nitrosoureas or mitomycin C; 2 months for UCN-01) and recovered

- No prior tyrosine kinase inhibitors within 5 times the half-life of the inhibitors

- At least 2 weeks since prior administration of a study drug in an exploratory
IND/phase 0 study

- At least 1 month since prior radiotherapy

- Prior topoisomerase I inhibitors allowed

- Concurrent bisphosphonates for any cancer allowed

- Concurrent androgen deprivation therapy for prostate cancer allowed

- No other concurrent investigational agents