Clinical trial · Interventional
Photodynamic Therapy in Treating Patients With Precancerous Esophageal Conditions or Early Stage Esophageal Cancer
A Phase II Study of HPPH Photodynamic Therapy for Treatment of High Grade Dysplasia, Carcinoma In-Situ or Early Intramucosal Adenocarcinoma in Barrett's Esophagus. Randomization to Two PDT Treatment Regimens of HPPH (2-1 [Hexyloxyethyl]-2devinylpyropheophorbide-a) and Light
- 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)
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that is absorbed by tumor cells. The drug becomes active when it is exposed to light, and kills tumor cells. HPPH may be effective in killing precancerous cells and tumor cells. PURPOSE: This randomized phase II trial is studying how well photodynamic therapy with HPPH works in treating patients with precancerous esophageal conditions or stage 0 or stage I esophageal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPPH | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive HPPH IV over 1 hour on day 1. Approximately 24 hours later, the lesion is exposed to laser light endoscopically.
- interventionNames
- Drug: HPPH
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive HPPH as in arm I, but at a higher dose, followed by laser light exposure.
- interventionNames
- Drug: HPPH
Primary outcomes (1)
- measure
- Efficacy
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed high-grade dysplasia, carcinoma in situ, or early intramucosal adenocarcinoma of the esophagus * Stage 0 or N0, M0 primary or recurrent disease * Diagnosis of Barrett's esophagus * Ineligible for or refused surgical resection * Requires endoscopy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 50-100% Life expectancy * Not specified Hematopoietic * WBC ≥ 4,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * PT ≤ 1.5 times upper limit of normal (ULN) Hepatic * Bilirubin ≤ 2.0 mg/dL * Alkaline phosphatase ≤ 3 times ULN * ALT ≤ 3 times ULN Renal * Creatinine ≤ 2 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No contraindication to endoscopy * No other malignancy except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free * No porphyria or hypersensitivity to porphyrin or porphyrin-like compounds PRIOR CONCURRENT THERAPY: Chemotherapy * At least 1 month since prior chemotherapy * No concurrent chemotherapy Radiotherapy * At least 1 month since prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics Other * At least 1 month since prior Nd-YAG laser therapy * At least 4 weeks since prior therapy for this disease
References
Publications (0)
Data not yet available