Clinical trial · Interventional
Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer
A Phase I and Pharmacokinetic Study of Sequences of NSC 655649 (Rebeccamycin Analogue) and Cisplatin Without and With Granulocyte Colony-Stimulating Factor Support Every 21 Days
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase I trial to study the effectiveness of rebeccamycin analog and cisplatin with or without filgrastim in treating patients who have advanced cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| becatecarin | Drug | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- See detailed description.
- interventionNames
- Biological: filgrastim
- Drug: becatecarin
- Drug: cisplatin
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven advanced malignancy that is refractory to prior therapy or unlikely to benefit from standard therapy (e.g., chemotherapy, radiotherapy, and surgery)
* Part I: Previously untreated OR minimally pretreated
* Ineligible for part I and considered heavily pretreated if:
* Prior radiotherapy to wide ports involving the pelvis or at least 25% of bone marrow
* Greater than 6 courses of prior combination chemotherapy including alkylating agent
* Prior nitrosoureas or mitomycin
* Widespread bone metastases with bone marrow involvement by bone marrow biopsy (positive bilateral bone marrow biopsy for lymphoma patients)
* Part II: Heavily pretreated as defined above
* Measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* SWOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Absolute neutrophil count greater than 1,500/mm\^3
* Hemoglobin greater than 9 mg/dL
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 mg/dL
Renal:
* Creatinine less than 1.5 mg/dL
Cardiovascular:
* No uncontrolled hypertension
* No angina pectoris
* No clinically significant, multifocal, uncontrolled cardiac dysrhythmias
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active serious infection
* No clinically severe peripheral neuropathy (grade 1 or worse)
* No nonmalignant medical condition that would preclude compliance or increase risk of participation in study
* No hypersensitivity to E. coli derived drug preparations
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No other concurrent colony stimulating factors for prophylactic purposes
Chemotherapy:
* At least 3 weeks since prior chemotherapy (6 weeks since prior nitrosoureas and mitomycin) and recovered
Endocrine therapy:
* No chronic oral corticosteroids
* No concurrent corticosteroids except as prophylactic antiemetic
Radiotherapy:
* At least 3 weeks since prior radiotherapy and recovered
Other:
* At least 1 month since prior investigational agent
* No prophylactic oral or IV antibiotics for neutropenia unless fever present
* No other concurrent anticancer treatment or investigational agentReferences
Publications (0)
Data not yet available