Bladder Cancer, Breast Cancer, CNS Cancer, Colon Cancer, Esophageal Cancer, Eye Cancer, Head and Neck Cancer, Otorhinolaryngologic Neoplasms, Pain, Pancreatic Cancer, Prostate Cancer, Uterine Cancer
Conditions
Keywords
Pain, HEENT cancer
Brief summary
The purpose of this study is to determine the safest dose of d-methadone that can be given, without causing severe side effects in most patients with chronic pain. Patients are being asked to participate in the Phase I portion of this study.
Interventions
DRUGd-Methadone
8 subjects to receive 40 mg d-Methadone twice a day
DRUGD-methadone
After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.
DRUGplacebo
After randomization, patients will take the study drug or placebo for 12 days and then they will cross-over to the opposite arm for another 12 days. The study will end on day 24.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase I and Phase II portions of the study: * 18 years of age or older * Chronic pain with average 24 hour intensity rated at least 3 on a verbal numerical scale from 0-10 during the 24 hours prior to study entry. * Give informed consent to participate in this study. * Karnofsky Performance Score (KPS) \>= to 80 * Negative urine pregnancy test, verified by the study nurse, at study entry (for women of child-bearing potential). Patients must also use a medically approved contraceptive method during the study period. Phase I only: * Responsible companion living with patient during study. Phase II only: * Group 1 -- Patients must be taking chronic opioid therapy (long acting morphine, long acting oxycodone, transdermal fentanyl) at a stable dose for a minimum of four days. The dose of as needed short acting opioid does not need to be stable. * Group 2 -- Patients must not be receiving opioids and must have cancer related neuropathic pain secondary to post-chemotherapy peripheral neuropathy, post-radiation and/or post surgical plexopathy, radiculopathy or neuropathy, or post- herpetic neuralgia.
Exclusion criteria
Phase I and Phase II: * Known hypersensitivity to methadone * Patient taking methadone or with a history of methadone treatment within one month of study enrollment. * Patient that requires changes in the dose of one of the following medications within 2 weeks of study enrollment: * Abacavir, * Benzodiazepines, * Carbamazepine, * Efavirenz, * Fluconazole, * Fluvoxamine, * FOS amprenavir, * Fosphenytoin, * Naltrexone, * Nelfinavir, * Nevirapine, * Phenytoin, * Rifampin, * Rifapentine, * Risperidone, * Ritonavir, * St. John's Wort, * Zidovudine * Hepatic function tests (SGOT, alkaline phosphatase, bilirubin) greater than 2 times the upper limit of normal or creatinine greater than 1.4 within 30 days of study entry. * Neurologic or psychiatric disease sufficient, in the investigator's opinion, to compromise data collection. * Women who are pregnant or nursing. * Women of childbearing potential who do not agree to use a medically recognized method of contraception during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Who Reached a Safe Dose | 2 years | The number of patients who reached a safe and well tolerated dose of d-methadone |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Receiving D-methadone 40 mg Patient Receiving D-methadone 40 mg | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible Patient | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Patients Receiving D-methadone 40 mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 9 |
| serious Total, serious adverse events | 2 / 9 |
Outcome results
Primary
Number Who Reached a Safe Dose
The number of patients who reached a safe and well tolerated dose of d-methadone
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I, Cohort l | Number Who Reached a Safe Dose | 8 participants |